“Trevena Announces Presentation of OLINVYK® Respiratory Safety Data in High-Risk Patients at the 46th Annual ASRA Meeting - GlobeNewswire” plus 2 more

“Trevena Announces Presentation of OLINVYK® Respiratory Safety Data in High-Risk Patients at the 46th Annual ASRA Meeting - GlobeNewswire” plus 2 more


Trevena Announces Presentation of OLINVYK® Respiratory Safety Data in High-Risk Patients at the 46th Annual ASRA Meeting - GlobeNewswire

Posted: 12 May 2021 04:00 AM PDT

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Elderly and obese patients receiving OLINVYK are not at increased risk for respiratory depression, compared to younger and non-obese patients, based on exploratory analysis

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CHESTERBROOK, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 46th Annual Regional Anesthesiology and Acute Pain Medicine (ASRA) Meeting. The conference is taking place on May 13th to 15th, 2021.

The poster highlights an exploratory analysis of respiratory safety data from the OLINVYK Phase 3 multi-site, open-label, "real world" study. The incidence of opioid-induced respiratory depression (OIRD) was similar between "high-risk" patients, defined as elderly and obese, and "low-risk" patients, defined as younger and non-obese. This lack of difference was observed despite the high-risk group having a higher average age, average BMI, comorbid burden, mean cumulative dose, and mean duration of exposure to OLINVYK. Advanced age and obesity are two well-recognized risk factors for developing OIRD.

"Complex patients with medical comorbidities pose unique challenges in postoperative pain management, due to their increased risk for developing adverse events such as respiratory depression," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "The findings from this analysis are important and suggest that OLINVYK may be a clinically appropriate treatment option for these challenging patients. Physicians still need to be mindful that life-threatening respiratory depression from opioids is more likely to occur in elderly patients. Physicians should monitor them closely, particularly when initiating and titrating OLINVYK and when OLINVYK is given concomitantly with other drugs that depress respiration."

Poster Details

"Low Incidence of Opioid-Induced Respiratory Depression Observed with Oliceridine In High-Risk Elderly Obese Patients" (Poster #979, 5:30-6:00 p.m. ET, May 13th, 2021)

  • High-risk patients (n=120) demonstrated a relatively low OIRD incidence of 10.8%, which was numerically lower than the OIRD incidence of 14.6% in low-risk patients (n=268) and 12.9% in all patients.
  • Out of 768 patients in the study, 33% were ≥ 65 years of age and 46% had a BMI of ≥ 30 kg/m2. The average age in the high-risk group was 70 vs. 45 years in the low-risk group. The average BMI in the high-risk group was 35.6 kg/m2 vs. 25.1 kg/m2 in the low-risk group.
  • The mean cumulative dose of OLINVYK was 37.1 mg in the high-risk group vs. 30 mg in the low-risk group. The mean duration of exposure was 39.8 hours in the high-risk group vs. 28.1 hours in the low-risk group.
  • There was a higher incidence of other medical comorbidities in the high-risk group, including asthma, sleep apnea, chronic obstructive pulmonary disease, diabetes, and hypertension, which are also known to increase the risk of OIRD.
  • OIRD was defined by administration of naloxone, a respiratory rate <10 bpm, or oxygen saturation < 90%. No naloxone administration was required for any patient treated with OLINVYK in the study.

The poster can be found at https://www.trevena.com/publications.

About OLINVYK® (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for epilepsy and chronic neuropathic pain, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

For more information, please visit www.Trevena.com 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com 
(617) 430-7576

PR & Media Contact:

Sasha Bennett
Director
Clyde Group
Sasha.Bennett@clydegroup.com 
(239) 248-3409


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Posted: 11 May 2021 07:28 AM PDT

Panlobular Emphysema: Overview and More - Verywell Health

Posted: 12 May 2021 06:42 AM PDT

Panlobular (or panacinar) emphysema is a type of emphysema that affects a specific part of the lungs. Emphysema is a disease of the lungs in which the air sacs in the lungs (alveoli) are permanently damaged. There are three emphysema types—centriacinar, panlobular, and paraseptal—that affect different parts of the lung structure.

You may have heard the term emphysema in relation to chronic obstructive pulmonary disease (COPD). COPD is an umbrella term that includes emphysema and chronic bronchitis. Statistics show that 16.4 million adults in the United States have a diagnosis of any type of COPD, chronic bronchitis, or emphysema.

Panlobular emphysema affects the whole acinus—which is the end portion of the respiratory bronchioles, including the alveolar ducts, alveolar sacs, and alveoli. It is an evenly distributed disease in which the tissue damage is uniform throughout the acinus and secondary pulmonary lobule.

athima tongloom / Moment / Getty Images

Panlobular Emphysema Symptoms

Panlobular emphysema causes chronic damage to the airways in the lungs. This damage can cause obstruction, making it difficult to breathe. 

Symptoms will vary depending on the person, history, and stage of the disease. However, common symptoms include:

  • Shortness of breath
  • A persistent cough
  • Difficulty performing activities of daily living (like washing, dressing, walking up/down stairs)
  • Weight loss
  • Fatigue
  • Loss of appetite
  • The production of excess sputum (phlegm/mucus)
  • Wheezing
  • Chest tightness
  • A blue tinge around the lips or in the fingernails/toenails 
  • Depression or anxiety
  • Frequent respiratory infections

Panlobular emphysema is a chronic disease and is irreversible. This means that symptoms worsen as the condition progresses.

Causes

Several conditions might be the root cause of panlobular emphysema, including:

  • COPD (predominantly found in severe COPD)COPD is caused by smoking or inhaling other irritants or air pollutants (in the workplace, for example). The irritant causes the inner walls of the air sacs to weaken, and the lining of the alveoli becomes damaged. The damage is irreversible and causes breathing problems. 
  • Alpha-1 antitrypsin deficiency (AATD):  AATD is a genetic condition in which you do not have enough of a protein/enzyme called alpha-1 antitrypsin (AAT). When AAT levels are low, your lung tissues are not well protected and are much more easily damaged by smoke or a lung infection. Damage to the alveoli can lead to emphysema.
  • Ritalin lung: Ritalin (methylphenidate) abusers can develop panlobular emphysema through injecting Ritalin intravenously. This is also sometimes known as excipient lung disease.
  • Swyer-James syndrome: Swyer-James syndrome is a very rare condition. It can affect either the whole lung or a portion of the lung. With this condition, the lung does not grow properly and is smaller than the opposite lung. It can follow having severe bronchiolitis or pneumonitis as a child, but how it is caused is not fully understood.
  • Obliterative bronchiolitis (also known as popcorn lung)Obliterative bronchiolitis is a rare disease caused by the inhalation of chemicals, exposure to a respiratory virus, or an autoimmune disease. It can also be associated with graft-versus-host disease following a lung or bone marrow transplant.

Diagnosis

Diagnosis begins with your primary care health professional, who will take a complete medical history. Your medical history will include things like:

  • Smoking history
  • Family history
  • Exposure to secondhand smoke
  • Exposure to chemicals, fumes, dust, or other irritants in the workplace
  • Allergy history
  • Previous lung diseases/childhood respiratory problems

If a type of emphysema is suspected, several other tests are carried out to confirm a diagnosis. These may include:

Diagnosing Panlobular Emphysema

Although other tests can confirm the diagnosis of emphysema, a physician can identify the diagnosis of panlobular emphysema only through CT imaging.

Mild or moderate disease can be challenging to detect, even with CT imaging. When panlobular emphysema is severe, the most common characteristics seen on a CT scan are:

  • Decreased lung attenuation
  • Few visible pulmonary vessels in the abnormal regions
  • Bullae or cysts are usually absent 

An experienced respiratory specialist will identify these characteristics after carefully reviewing the CT scans.

Treatment

Treatment of panlobular emphysema can vary slightly depending on the root cause; however, many treatments remain the same regardless. 

Treatment can include:

  • Inhaled medications: Such as bronchodilators or steroids
  • Oral medicines: Such as antibiotics and steroids
  • Home oxygen therapy: Might be prescribed if oxygen levels in the blood are deficient
  • Pulmonary rehabilitation: An exercise and education program for people with lung disease to help you achieve more exercise with less shortness of breath
  • Nutritional advice: For some people, emphysema can cause weight loss. Therefore, a dietitian can provide advice on the best foods to help you maintain a healthy weight.
  • Vaccinations: Ensuring vaccinations are up to date to help prevent lung conditions such as pneumonia, flu, or COVID-19
  • Surgery: Lung reduction surgery, or a lung transplant, may be recommended in severe circumstances.

Treatment of panlobular emphysema aims to manage the symptoms and slow disease progression. 

Prognosis 

Panlobular emphysema, just like other types of emphysema, is irreversible. There is no cure.

Although it is a chronic condition, you can manage it through an individualized treatment plan that includes medication, exercise, dietary advice, and refraining from smoking/exposure to air pollutants.  

When diagnosed early, a treatment plan can help slow the disease progression. If smoking is the cause, then quitting is vital to slowing down the disease's progression. However, over time symptoms will worsen as the disease progresses.

Prognosis varies significantly from person to person depending on the severity of the emphysema, root cause, medical history, lifestyle, family history, overall health, and medication adherence. 

Coping 

Coping with panlobular emphysema and breathlessness can be challenging. It can lead to symptoms of depression or anxiety, especially if breathlessness is affecting everyday life. 

If you are experiencing feelings of depression or anxiety, your primary care health professional or respiratory medical team can help. Therapy, such as cognitive-behavioral therapy, can help with depression, anxiety, and managing symptoms of breathlessness.

Learning relaxation techniques such as breathing exercises, visualization, and meditation can also help with breathlessness and anxiety symptoms. 

There are support groups available for people with various types of lung conditions. Being around other people with a similar lung disease can show you that you are not alone, provide peers to talk to, and signpost you to relevant support. 

It is important to remember that you are not alone, and that there is a lot of support and advice available. 

A Word From Verywell 

Like any type of emphysema, panlobular emphysema can be difficult to live with. At times, breathlessness can be pretty daunting. However, there are many treatments and techniques available to help slow the progression of the disease and help with symptom management.

Be sure to seek medical advice if you are worried that you have problems with your breathing. The sooner emphysema is identified, the sooner you can start a treatment plan and appropriate medications. Doing your best to quit smoking, avoid infections, eat a varied diet, and exercise are some of the best ways to stay as healthy as you can. 

Talk to your healthcare professional or respiratory team if you are struggling to cope with panlobular emphysema. There are many ways they can offer support to make living with the condition more manageable.

Comments

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