– Hospital charge database study shows high prevalence of opioid-related adverse events in key surgical specialties despite use of multimodal analgesia –
– Physician survey highlights the need for new options for patients who require IV opioids but are at risk of opioid-related adverse events –
CHESTERBROOK, Pa., Sept. 07, 2017 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) today announced results from three poster presentations given during PAINWeek® 2017, held at The Cosmopolitan Hotel in Las Vegas, Nevada, September 5-9. The presentations described new data highlighting the burden of opioid-related adverse events in hospital patients who require intravenous (IV) opioids to manage their pain, and identified specific procedures and patient characteristics associated with elevated risk of acute opioid-related adverse events.
“These hospital database and survey data show that conventional IV opioids remain a necessary component of acute postoperative pain management, despite their many drawbacks,” said Peter Whang, M.D., FACS, Associate Professor of Orthopaedics & Rehabilitation at Yale University School of Medicine. ”The findings highlight that patients who most require IV opioids, but are at elevated risk from opioid-related adverse events, reflect an important unmet need for new analgesic options.”
Two of the poster presentations described the results of a study assessing patient characteristics and other predictors of post-operative nausea/vomiting (PONV) and opioid-induced respiratory depression (OIRD) associated with the use of conventional parenteral opioids to manage acute postoperative pain. The study assessed 592,127 hospital stays in the Premier Perspectives® Hospital Database for general/colorectal, orthopedic, OB/GYN, cardiothoracic/vascular, and urologic procedures. These procedures are associated with severe and prolonged pain, and with patient risk factors that have been suggested to elevate the risk for opioid-related adverse events. Despite the widespread use of multimodal analgesia, substantial doses of parenteral opioids were administered to these patients, ranging from 27 mg to 79 mg of morphine equivalents per day. This was associated with high rates of OIRD, with incidence from 3% to 17% across the different surgical specialties. Obesity, respiratory conditions, and sleep apnea were significantly associated with an increased likelihood of OIRD. The study also found high rates of PONV, with incidence ranging from 44% to 72%. Female patients and younger patients were found to have an increased likelihood of PONV. The prevalence of these adverse events was higher in this database’s population than broader hospitalized patient populations studied in previous publications.
A third poster described a recent survey of 501 physicians on their practice patterns in managing acute postoperative pain. Results indicate that both patient characteristics (such as chronic opioid use, age, and respiratory comorbidities) and opioid-related adverse events (such as nausea, vomiting, and respiratory depression) remain a common challenge in postoperative pain management and play a key role in influencing treatment decisions, particularly in high-risk patients.
Poster presentations: Thursday, September 7, 6:30 – 8:30 p.m. PDT
• Poster Number 4: Predictors of Post-Operative Nausea or Vomiting Associated with Opioid Treated Acute Postoperative Pain. Anthony J. Senagore, Ashraf S. Habib, Kellie Morland, Sheikh Usman Iqbal, David Soergel, Marla Kugel, Sizhu Liu, and Gary Oderda
• Poster Number 5: Predictors of Opioid-induced Respiratory Depression Associated with Acute Postoperative Pain Treatment. Ashraf S. Habib, Anthony J. Senagore, Kellie Morland, Sheikh Usman Iqbal, David Soergel, Marla Kugel, Sizhu Liu, and Gary Oderda
• Poster Number 96: Physician Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management. Tong-Joo Gan, Robert Epstein, Barbara Menzel, Megan Leone-Perkins, Tehseen Salimi, Sheikh Usman Iqbal, and Peter G. Whang
Abstracts may be accessed online at: http://conference.painweek.org/scientificposters.
Trevena, Inc. is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions. The Company has discovered four novel and differentiated drug candidates, including OLINVO™ (oliceridine injection), for the management of moderate-to-severe acute pain, TRV250, for the treatment of acute migraine, and TRV734 for pain. The Company maintains an early stage portfolio of drug discovery programs.
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 of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and 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 status, timing, costs, results and interpretation of the Company’s clinical trials, and the expected timing of the NDA submission for OLINVO; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates, including whether IV opioids remain a necessary component of acute postoperative pain management; 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.
Jonathan Violin, Ph.D.
Vice President, Corporate Strategy & Investor Relations
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