“What 'Rocketman' Tells Us About Pain and Addiction - Pain News Network” plus 3 more
“What 'Rocketman' Tells Us About Pain and Addiction - Pain News Network” plus 3 more |
- What 'Rocketman' Tells Us About Pain and Addiction - Pain News Network
- Medical marijuana: A Catch-22 for Florida residents, researchers - Florida Trend
- 5 potential complications of COPD - Medical News Today
- New Data from the RECOVER(TM) Study Reports on Abstinence, Drug Craving and Psychosocial Outcomes in People with Opioid Use Disorder following Transition from a Clinical Trial to the Real-World Setting - P&T Community
| What 'Rocketman' Tells Us About Pain and Addiction - Pain News Network Posted: 15 Jun 2019 12:01 AM PDT By Lynn Webster, MD, PNN Columnist "Rocketman" is a new biopic about the legendary singer Elton John. The emotionally-driven musical fantasy takes some liberties with certain details of John's life, but it illuminates an essential truth: childhood trauma can lead to pain, addiction and other severe health problems. The movie is generating some Oscar buzz, but it offers more to viewers who want to see how painful childhood experiences can adversely affect people when they become adults. The film begins with the flamboyantly wealthy and gifted Elton John strutting down a hallway -- in full costume complete with a colorful headpiece from a recent stage show -- to his first Alcoholics Anonymous meeting. He becomes the center of attention at the AA meeting when he begins to describe -- through flashbacks told, in part, through song and dance -- his childhood, which was devoid of love and acceptance.  "rocketman" Paramount pictures Elton John is a musical prodigy, but his talent couldn't save him from the harm caused by a father who rejected him and a mother who didn't protect him. As John told The Guardian, "My dad was strict and remote and had a terrible temper; my mum was argumentative and prone to dark moods. When they were together, all I can remember are icy silences or screaming rows." As John remembers it, "The rows were usually about me, how I was being brought up." How Childhood Trauma Affects HealthIn her TED Talk, Dr. Nadine Burke Harris describes how childhood trauma can affect health over a lifetime — laying the foundation for seven out of 10 leading causes of death in the United States, including addiction and even suicide. As Dr. Harris points out, our healthcare system treats childhood trauma as a social or mental health problem rather than as a medical issue. Doctors are trained to refer traumatized children to specialists rather than providing intervention and treatment themselves. But childhood trauma may lead to serious medical problems and can even reduce life expectancy by 20 years, according to a study published in the American Journal of Preventive Medicine. The CDC's Adverse Childhood Experiences Study (also known as the ACE Study) defined and examined this problem. The study acknowledged 10 types of childhood trauma, including verbal, physical, and sexual abuse; parental rejection and neglect; mental illness or incarceration of a family member; divorce; and substance dependence. Of the 17,000 adults who participated in the study, two-thirds had experienced at least one of these childhood traumas. Eighty-seven percent had lived through more than one. The consequences of this can be staggering. People who experienced four childhood traumas were 2.5 times more likely to have pulmonary disease and hepatitis. And they were four times more prone to depression and had 12 times the risk for suicidality. "Adverse childhood experiences are the single greatest unaddressed public health threat facing our nation today," says Dr. Robert Block, President of the Academy of Pediatrics. Trauma Rewires the BrainAdverse childhood experiences rewire the brain. The heightened response to stress that some children develop can affect the reward center of the brain and the executive functioning of the prefrontal cortex. It can also result in maladaptive behaviors associated with pain and addiction. About a decade ago, Dr. Norman Doidge provided an understanding of how our brains have the capacity to change in his book, "The Brain that Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science." His highly acclaimed research offers scientific hope that there is treatment for the adverse effects of childhood trauma and chronic pain. Dr. Doidge describes neuroplasticity as the process through which an injured brain can heal itself. An example of this healing process was reported by National Public Radio's Patti Neighmond. It is called emotional awareness and expression therapy (EAET). Developed in 2011 by psychologist Mark Lumley and Dr. Howard Schubiner, EAET combines talk therapy with cognitive behavioral therapy to change brains that have been structurally altered by trauma. The NIH's Pain Management Best Practices Inter-Agency Task Force has recognized EAET as potentially beneficial to some people in chronic pain. Preventing the Need for Drugs"Rocketman" reflects more than the consequences of a single individual's traumatic childhood. It illuminates a broader social problem that sows the seeds for substance use disorders in adults. The approach we take to solving substance use disorders today is focused on treatment and law enforcement. Neither approach seems to be curbing the problem, which suggests the need for a better strategy. Long-term solutions to substance use disorders must include prevention. This means we need to understand what creates the demand for drugs. Elton John's story poignantly illustrates two of the causes of addictive behavior:
There is compelling evidence that the trajectory of our mental and physical health begins with how we are treated as children. It may seem Pollyannish to say this, but our first line of defense is to love and accept our children, regardless of their gender identity, abilities or individual traits. As "Rocketman" testifies, anything else can set children on the path to developing a substance use disorder and, in some cases, chronic pain.  Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, author of the award-winning book "The Painful Truth" and co-producer of the documentary "It Hurts Until You Die." You can find him on Twitter: @LynnRWebsterMD. The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author's opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network. | |
| Medical marijuana: A Catch-22 for Florida residents, researchers - Florida Trend Posted: 18 Jun 2019 08:27 AM PDT  Ask nearly any scientist in Florida who wants to conduct clinical research on cannabis, and expect to hear echoes of a similar strain: The status of medical marijuana in the Sunshine State is currently hazy -- ask again later. But for thousands of chronically ill patients who rely on the relief they insist cannabis provides, waiting on science is not an option when quality of life is at stake. Dr. Karen Forsythe Monroe, a Pinellas County physician who is licensed to recommend medical cannabis to qualified adults in Florida, maintains morning hours at her St. Pete office. She spends her afternoons making home visits with patients who are housebound by chronic illness or pain. "I look at the patient, and I ask: Are they really suffering? ... They're old and they're sick. That's what I'm seeing. The people who are coming to me -- they don't want to get high. They just want their pain to go away," Monroe says. A supermajority of Florida voters approved legalizing marijuana for medical use when they voted in favor of Amendment 2 in 2016. But as of today, the state's doctors and researchers say they're still waiting for the smoke to clear before cannabis can make concrete clinical progress. Here's an abridged recap of medical marijuana's recent history in Florida:
Studies stall for decades With the passing of Amendment 2 and the subsequent Senate Bill 8A in 2017, Florida legalized medical cannabis for 10 qualifying conditions: cancer, epilepsy, glaucoma, HIV, AIDS, Post Traumatic Stress Disorder (PTSD), Amyotrophic Lateral Sclerosis (ALS), Crohn's Disease, Parkinson's Disease, and Multiple Sclerosis (MS), as well as "medical conditions of the same kind or class as or comparable to the above qualifying conditions," such as Generalized Anxiety Disorder. Tasked by state law to furnish the OMMU with research that supports her cannabis recommendation for each patient, Dr. Monroe notes that anecdotal and observational evidence of cannabis' efficacy in treating conditions including but not limited to appetite loss, nausea, pain, and anxiety is abundant, but digging up existing science that meets what she calls the "Research Gold Standard" -- the double-blind, randomized, placebo-controlled study -- is like looking for a needle in a hemp stack. The problem with tracking down solid research on medical cannabis in the United States? It hardly exists. Why? Because doing the research is a felony. Superseding state law, federal restrictions on the Cannabis sativa plant paint a murky landscape for patients, doctors, and scientists. The Marihuana Tax Act of 1937 and the Controlled Substances Act of 1970 placed cannabis' long-standing medicinal claims at odds with the plant's legal status: Since the Nixon administration, the Cannabis sativa plant is classified alongside heroin and LSD on the federal list of Schedule 1 Controlled Substances. In other words: as of June 1, 2019, Florida is among 33 states and the District of Columbia, where qualifying patients may, according to state law, purchase and use cannabis products for medicinal purposes. Eleven additional states permit recreational cannabis. However, as of June 1, 2019, the U.S. Drug Enforcement Agency (DEA) classifies cannabis by its Schedule 1 definition: a drug with high potential for abuse and zero medical value. Dr. Kevin Sneed, founding Dean of the University of South Florida College of Pharmacy and Senior Associate VP of USF Health, hopes to attain DEA approval to conduct clinical cannabis trials at the university. "Most of what's out in the medical literature is either anecdotal or observational -- or, in most cases, it's just not a well-done or credible study. Here at USF, we are making attempts to work directly with the DEA," says Sneed. Even in states where cannabis is legal for medical as well as recreational use, such as Colorado, researchers who wish to perform clinical trials on the plant must apply for a Schedule 1 DEA research license. Once approved, scientists are permitted to study only cannabis that is sourced from the federal crop located at the University of Mississippi and overseen by the National Institute for Drug Abuse (NIDA). Dr. Sneed says USF aims to achieve "very coherent, very well-done clinical trials" on the safety and effectiveness of compounds found in the Cannabis sativa plant -- specifically, those compounds' effects on what Sneed calls "bio-inflammatory pathways in the body" -- and new, non-euphoric formulations for their delivery. Sneed notes, however, that until USF researchers receive a green light from the DEA, achieving clinical results is not worth risking doctors' careers or patients' safety. "We want to make sure we're going through every legal pathway to protect the patient, our researchers, and the integrity of what we're doing," says Sneed. "As it stands, we're being patient. We have not engaged in any [cannabis research] because we are not authorized to do it. But we understand what needs to be done, we know why it needs to be done, and when the time comes -- we're ready to do it," he adds. Cannabinoid conundrum: To CBD or not to CBD? What about THC? More than 100 chemical compounds make up the Cannabis sativa plant. The plant's two most buzzed-about cannabinoid compounds, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), dominate most of the conversation surrounding medical marijuana. Although conventional science is limited, current evidence indicates that THC is the cannabinoid responsible for cannabis' psychoactive effects -- in other words, it's what gets people "high." Although THC is largely implicated for the psychoactive properties that give cannabis its dodgy reputation and Schedule 1 classification, there are scores of unanswered questions, or inadequately researched theories and observations, about the possible benefits this cannabinoid could offer, in what dosages, and by what delivery. Scientists are interested in how THC might help reduce nausea and wasting in HIV and AIDS patients, or those undergoing chemotherapy for cancer, as well as its possible role as an anti-inflammatory, and the ways the cannabinoid may interact with or replace opioids as a treatment for chronic pain. A separate cannabinoid, CBD, exhibits demonstrable success in treating severe forms of childhood epilepsy -- and possibly also includes powerful anti-inflammatory and anxiety-reducing benefits yet to be defined in a lab. But CBD comes to the table without any of the psychoactive side effects attributed to THC. CBD and THC are just two among at least 113 compounds that comprise the Cannabis sativa plant, but CBD may be the first to show up to traditional medicine -- namely, in pediatrics -- with some solid pharmaceutical receipts. In 2018, Epidiolex, the first FDA-approved pharmaceutical formulation of plant-derived CBD, hit the market to treat two rare and severe forms of childhood epilepsy: Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome. Epidiolex exists in pharmacies today, largely thanks to Colorado parents Paige and Matt Figi who in 2013 tried oil derived from a CBD-dominant, low-THC cannabis strain in a desperate, last-ditch effort to reduce the frequency of severe epileptic seizures suffered by their 5-year-old daughter Charlotte. Charlotte's seizures began when she was 3-months-old. By age 5, she was having 300 grand mal seizures a week. The seizures were reduced to just twice monthly, on average, when the Figis introduced the CBD oil. Originally nicknamed "Hippie's Disappointment" because of the "disappointing" lack of psychoactive effects due to its scarce THC content, the CBD-dominant strain that helped soothe Charlotte Figi's seizures later became known as "Charlotte's Web." It opened the door for clinical research on CBD, and ultimately, the first FDA-approved, plant-derived prescription CBD pharmaceutical Epidiolex. In spite of CBD's budding promise, the lack of available research on this cannabinoid and on THC means there remain more unknowns than there are understandings about the role of Cannabis sativa as medicine. Re-scheduling hemp: Will the Federal Farm Bill change the playing field? Consumer Reports found that an estimated 64 million Americans have taken CBD, and that 63% find it effective for the condition they were trying to treat. In a telephone survey of 4,355 adults, 40% said they receive their CBD from a dispensary and 25% purchase it online. Most respondents report price as their main concern. Only 13% of respondents report safety as a high-ranking concern, and more than half are confident there are regulations in place on CBD. There are not -- yet. The Agricultural Improvement Act of 2018, also known as the Farm Bill, removes hemp as a Schedule 1 substance and re-classifies it as an "agricultural commodity." By removing federal restrictions on hemp that date back to 1937, the Farm Bill authorizes states to create hemp programs beyond university settings. It also both clarifies and complicates the conversation surrounding medical applications of Cannabis sativa by legally defining what is "medical marijuana" and what is "hemp" -- both of which derive from the same plant. Per the Farm Bill, Cannabis sativa plants containing more than 0.3% of the psychoactive cannabinoid THC are considered "medical marijuana." Cannabis sativa plants containing less than 0.3% THC are "hemp." CBD may be sourced, by a variety of methods, from Cannabis sativa plants that are classified as medical marijuana as well as those that are classified as hemp. Currently, the lion's share of CBD products sold in Florida dispensaries contains THC levels that are slightly or significantly above the 0.3% limit -- thus requiring an OMMU license to acquire. "Hemp-derived" CBD products that can be purchased over-the-counter, for instance in Florida gas stations or online, claim to contain less than 0.3% THC. However, consumers have no way of knowing whether this is the case -- or what other ingredients may lurk within -- because there is currently zero regulation on hemp oils and no federal lab standard for testing CBD products in the United States. The only lab-verified CBD products on the Florida market are those sold in state-licensed dispensaries operated by Medical Marijuana Treatment Centers (MMTCs) -- who also operate their own laboratories. On May 31, 2019, in the FDA's historic first-ever public hearing on CBD, DEA-approved Schedule 1 researcher, Elise Weerts of Johns Hopkins University, underscored scientists' cannabinoid conundrum: "My 21-year-old son can walk into a store and buy [any cannabis product] and I cannot purchase, store, or test that product. It is illegal for me to do so." As a Schedule 1 controlled substance, it is also a felony for medical marijuana (cannabis containing more than 0.3% THC) to cross state lines. This means that all cannabis products sold in Florida dispensaries and consumed by qualified Florida patients must be cultivated in-state by licensed, private MMTC grow operations. How cannabinoid profiles in these dozens of MMTC-grown strains on the Florida market compare with that of the NIDA crop in Mississippi -- which celebrated its 50th anniversary in 2018 -- is, and will remain, indefinitely, under current federal restrictions, unknown. Where does this leave research efforts to verify any of the CBD and THC-containing cannabis products that are currently being smoked, vaped, swallowed, or applied topically or sublingually by thousands of medical cannabis patients, as well as countless people who purchase over-the-counter hemp and CBD in the state of Florida today? The answer is currently hazy. Ask again later. Oh, and -- head's up, hemp-derived CBD users in Florida: Until Senate Bill 1020 (the State Hemp Program approved by Tallahassee lawmakers in May) goes into law on July 1, possession of hemp is still a criminal act. It's been that way since 1937. Reaching around the restrictions to do the research One way scientists working within the public university system in Florida are able to collect data on medical cannabis, without touching the plant, is simply by asking patients. In 2017, University of Florida Professor in Epidemiology Dr. Robert Cook, Director of the Southern HIV and Alcohol Research Consortium (SHARC) and Chair of the Florida Consortium for HIV/AIDS Research (FCHAR), was awarded a $3.2 million NIDA grant to conduct a 400-person longitudinal cohort study of persons living with HIV who report using cannabis. "In terms of restrictions on research, I certainly can't use federal research money to purchase marijuana products, and I can't ask people to bring products onto campus. This grant was written to find out what people are doing on their own -- self-medicating," says Dr. Cook. The study, held in collaboration with USF and FIU, aims to collect data on patients' self-dosing habits and to identify relationships between cannabis consumption and HIV symptoms, HIV viral suppression, markers of chronic inflammation, and cognitive or behavioral aspects of health. Participants can self-report what type of cannabis products they are consuming, how much, and document their anecdotal experiences via questionnaires. They also undergo blood and urine tests to determine markers of inflammation, as well as toxicology reports that break down the specific components in the cannabis the individual is using. "Some of the trickiness [of studying medical cannabis] is that the marijuana plant has all of these components together -- some call it a potential 'entourage effect.' The traditional medical community that is interested in evaluating whether a drug works has to have that drug tested in a specific dose and condition. But people in the real world are using marijuana off the street, some are getting it from dispensaries, and many say they're self-treating things like sleep or pain -- so the purpose of our grant is to try to describe what people are doing on their own," Cook says. While the study doesn't offer the controlled laboratory precision that researchers like Dr. Sneed at USF hope to achieve with a Schedule 1 DEA research license, Cook says, longitudinal, survey-based studies like his provide opportunities to develop insights about real-world cannabis use. "If we follow people for three to four years, we do think some will start using, and that some will stop, and those will be opportunities for us to see how changes in marijuana use impact changes in health," Cook says. Cook notes there are benefits as well as pitfalls to researching cannabis through federal channels. "One downside to that kind of research is that the marijuana needs to stay on campus -- but in the real world, people are getting up to seven months of product at a time. There are certain types of questions that are good to ask with the [cannabis] that comes from Mississippi -- and one benefit is that it's a standardized dose. But is that what people are actually doing? A lot of people are nervous that if someone uses a [MMTC grown] product, will it be the same?" When state legislation tangles with scientific endeavors Dr. Jenny Wilkerson, Research Assistant Professor at the UF College of Pharmacy, admits to feeling burned by the conflict between medical cannabis research efforts and recent legislative decisions in Florida. Prior to joining the University of Florida in 2017, Wilkerson most recently completed a postdoctoral fellowship at Virginia Commonwealth University, where her research emphasized the endocannabinoid system -- the system in the body that interacts with cannabis. Following the passing of Amendment 2, the Florida Legislature in 2016 established the Medical Marijuana Research and Education (MMRE) board, which was to be funded by taxes levied against licensed medical marijuana growers in Florida, and operated through the Moffitt Cancer Center. Wilkerson applied for the first MMRE monies available to researchers outside Moffitt in the 2018-2019 funding cycle, and received notification in June 2018 that she was recommended to receive $200,000 to fund her medical marijuana research project, titled "De-hazing the Role of the Immune System in Cannabinoid-Mediated Mitigation of Chemotherapy Side Effects." "Here, I was going to look at THC in a mouse model of chemotherapy-induced pain and examine if THC's mechanism of action is via the immune system. I was also going to examine respiratory depression due to opioids. We know that opioids are commonly prescribed for cancer pain. However, there is a little bit of evidence that suggests that chemotherapy increases susceptibility to opioid-induced respiratory depression. However, this hasn't been systematically studied," Wilkerson explains. A $200,000 grant "would have been huge," she says. "This would have allowed me to start my independent research at a competitive level -- paying the salary for two full-time research laboratory technicians, as well as all related costs of my proposed research." The operative phrasing, of course, is "would have been ..." "This grant by the state of Florida would have kick-started my career as a young scientist. It's partially why I chose to come to UF as opposed to going to an industry job in Boston … But then [our MMRE funding] got pushed back -- apparently via pushback from lobbyists in Tallahassee who thought the tax on growers was too high," Wilkerson says. She then notes, "in January, our new governor signed a bill to basically dissolve the entire MMRE program. I've never seen the money I was supposed to get." The new Florida Legislature under Gov. DeSantis dissolved Moffitt's medical professional-led MMRE board in early 2019 and passed along the appropriation of MMRE research monies -- including that previously awarded to Wilkerson -- to the oversight of the Florida Board of Governors. In addition to shuffling pre-allocated funds, the new MMRE board, the Consortium for Medical Marijuana Clinical Outcomes and Research, also states that its sole focus on clinical cannabis research should be on humans, meaning cannabis research using animals, such as Wilkerson's chemotherapy lab mice, will not be funded. It leaves Wilkerson in a tight and frustrating spot -- and puts what she believes to be valuable research on hold, indefinitely. "I put in for a grant from the NIH, but unfortunately the criteria to get a grant from the NIH is very high. To get $200,000 [MMRE funding] for a year would have allowed me that extra money and time to put together a much stronger research portfolio -- one that I believe would be very compelling for the NIH." In the meantime, working under UF Professor and Chair of the Department of Pharmacodynamics, Lance McMahon, Wilkerson plugs away at what research she is able to conduct -- mostly, she says, using McMahon's own startup money to fund CBD studies. "I've had to be more creative, and I've had to not answer some of those questions I think are so important -- like the respiratory depression issues. I've had to scale down my research endeavors significantly," Wilkerson says. When might Wilkerson be able to pursue the cannabis research she deems vital to create guidelines for safe and responsible medical marijuana use in the state of Florida? Ask lawmakers in Tallahassee and Washington D.C. As for now, you can predict a familiar response: The status of medical marijuana is currently hazy. Ask again later. Author's Note: On June 13, 2019, the Board of Governors selected the University of Florida to lead the Consortium for Medical Marijuana Clinical Outcomes Research, stating: "The purpose of the consortium is to conduct rigorous scientific research and disseminate such research. The consortium shall include both public and private universities and research must include tracking clinical outcomes, certification standards, dosing standards, routes of administration, efficacy, and side effects; and the study of the effects of smoking marijuana to treat debilitating medical conditions (section 1004.4351, Florida Statutes)." As the lead institution, UF will receive $1.5 million in recurring funding from the state of Florida to build a data repository known as the Medical Marijuana Clinical Outcomes Repository (MEMORY), develop a clinical research core, and establish a competitive grants program offering $600,000 annually from the state appropriation to participating institutions. To learn more, visit these links: | |
| 5 potential complications of COPD - Medical News Today Posted: 03 Sep 2018 12:00 AM PDT You have chosen to share the following article: How elderberries can help you fight the flu To proceed, simply complete the form below, and a link to the article will be sent by email on your behalf. We do not store details you enter into this form. Please see our privacy policy for more information. Message sent successfullyThe details of this article have been emailed on your behalf. Click here to return to the Medical News Today home page. | |
| Posted: 17 Jun 2019 11:43 AM PDT SLOUGH, England and RICHMOND, Va., June 17, 2019 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced new data from a one-year analysis of the observational RECOVER™ (Remission from Chronic Opioid Use-Studying Environmental and Socio-Economic Factors on Recovery) study examining long-term recovery in individuals with opioid use disorder after transition from a pivotal Phase III clinical trial to a real-world setting.
The results were reported at the 81st Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD) in San Antonio, TX. "These findings help us better understand the role of long-acting treatments, such as SUBLOCADE, in helping patients maintain long-term recovery from opioid use disorder," said Walter Ling, M.D., Professor Emeritus of Psychiatry and Founding Director of the Integrated Substance Abuse Programs (ISAP) at UCLA, who reported the RECOVER study findings. "I am particularly excited about the data we are seeing from RECOVER because it is giving us new insights into how these patients with opioid use disorder are managing in the real world after clinical trial participation." RECOVER is measuring abstinence in three ways: negative urine drug screens, no self-reported past week use and a combination of both (i.e., having both a negative urine drug screen and no self-reported opioid use), which is the measure reported here. The RECOVER study is also tracking patient success beyond measuring opioid abstinence. Participants who did not continue MOUD experienced less drug craving than participants who continued MOUD, which investigators suggest may indicate less pre-occupation with drug memories and successful avoidance of drug triggers in the no MOUD group. Participants in both groups reported similar rates of psychological distress and depression, as well as functional impairment like the inability to meet daily family, work or school responsibilities, which are common challenges for patients recovering from opioid use disorder. About the RECOVER™ Study The RECOVER (Remission from Chronic Opioid Use-Studying Environmental and Socio-Economic Factors on Recovery) study is a multisite, non-interventional cohort study examining long-term recovery in individuals with moderate to severe opioid use disorder who received at least one dose of study treatment during the Phase III clinical trials (NCT02357901 and NCT02510014) for SUBLOCADE.1 Results are being analyzed to understand the clinical, socio-economic and environmental factors associated with continuous effects of MOUD after a clinical trial.1 Participants (n=533) were eligible to join the RECOVER study 28 days after completing or terminating participation in the SUBLOCADE Phase III trials.1 The RECOVER study uses data from three main sources: self-administered assessments from enrolled individuals, urine drug screens (UDS) and data collected from several public sources.1 Recovery is examined over 24 months – the self-administered assessment and UDS results are completed by participants every three months over the course of this period.1 "Our investment in the RECOVER study reflects our commitment to tracking patient progress in the short-, medium- and long-term to continue to empower patients and providers with information that helps them treat their opioid use disorder," said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior. Post-hoc analysis evaluates abstinence responses to monthly SUBLOCADE maintenance doses of 300 mg versus 100 mg in people who inject opioids Indivior presented new post-hoc analyses from SUBLOCADE 24-week Phase III clinical trials suggesting that people with moderate to severe opioid use disorder who inject opioids may benefit from the higher 300 mg once-monthly SUBLOCADE maintenance dose. SUBLOCADE is administered as two initial monthly doses of 300 mg followed by monthly maintenance doses of either 100 mg (300/100 mg) or 300 mg (300/300 mg). Non-injecting opioid users achieved maximal response at buprenorphine plasma concentrations of 2.5 to 3 ng/mL, while injecting opioid users achieved maximal response at concentrations closer to 6 ng/mL. These laboratory findings aligned with improved clinical outcomes showing a significantly higher mean percentage of abstinence among injecting users maintained on the 300 mg dose (60.1%) compared to those maintained on the 100 mg dose (45.3%) for a risk-adjusted difference of just under 15%. "The SUBLOCADE dosing regimens were designed to deliver sustained buprenorphine plasma concentrations of at least 2 ng/mL that are needed to block the subjective effects of opioids in most subjects," according to Dr. Heidbreder, "But years of experience working to improve outcomes for patients with opioid use disorder have taught us that treatment options are not one-size-fits-all. Indivior is planning additional studies to further characterize the patients who may benefit from the higher maintenance dose of SUBLOCADE." About SUBLOCADETM SUBLOCADE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days.2 It should be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support.2 The overall safety profile for SUBLOCADE, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions.2 Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue and injection site pain. Injection site reactions were reported in 16.5% of patients in Phase 3 studies.2 Most of the injection site adverse reactions (ADRs) were of mild to moderate severity.2 None of the injection site reactions were serious, and one led to study treatment discontinuation.2 SUBLOCADE has a BOXED WARNING and is available through restricted distribution under the SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) Program.2 Pursuant to the SUBLOCADE REMS, all healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified and establish processes and procedures to verify the medication is dispensed directly to a healthcare provider for administration by a healthcare provider and is not dispensed directly to the patient.2 Moreover, certified healthcare settings and pharmacies must not distribute, transfer, loan or sell SUBLOCADE.2 INDICATION AND USAGE SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support. IMPORTANT SAFETY INFORMATION
Prescription use of this product is limited under the Drug Addiction Treatment Act. CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS For further product information, see full Prescribing Information including BOXED WARNING and Medication Guide at www.SUBLOCADE.com. About Opioid Use Disorder (OUD) Opioid use disorder (OUD), sometimes referred to as opioid addiction, is a chronic disease.2 According to DSM-5, "OUD is characterized by signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances that are used for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, they are used in doses greatly in excess of the amount needed for that medical condition."3 Based on 2016 data from the National Survey on Drug Use and Health report, approximately 11.8 million Americans (age 12+ years) engaged in misuse of opioids in the past year.4 From 1999 to 2017, the rate of deadly prescription opioid overdoses increased five-fold.5 In 2017, an average of 130 people died of opioid overdose each day in the United States.6 In addition, in 2016, 948,000 Americans (age 12+ years) used heroin and approximately 626,000 Americans (age 12+ years) had a heroin use disorder.4 In 2016, opioids accounted for more than 70% of the disease burden associated with drug use disorders worldwide.7 About Indivior Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. Our vision is for all patients around the world to have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. The name is the fusion of the words individual and endeavor, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior. Forward-Looking Statements This press release contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group's financial guidance for 2019 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation. Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group's products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group's drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group's products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group's ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group's products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items. This press release does not constitute an offer to sell or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation. THE RECOVER STUDY, RECOVER Logo and SUBLOCADE are trademarks of Indivior UK Ltd. All rights reserved. © Indivior PLC | INDIVIOR is a registered trademark of Indivior UK Limited | All rights reserved References
SOURCE Indivior |
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