Trevena to Present Phase 3, Open-Label Safety Study of Oliceridine at the American Society of Anesthesiologists Annual Meeting
CHESTERBROOK, Pa., Oct. 12, 2018 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ: TRVN) today announced a poster presentation at ANESTHESIOLOGY® 2018, the national conference for the American Society of Anesthesiologists (ASA), taking place in San Francisco, CA, from October 13 – 17, 2018.
The poster presentation highlights data from a large, open-label safety study evaluating oliceridine under conditions intended to emulate real-world practice in hospital patients with moderate to severe acute pain requiring intravenous (IV) opioids across a broad spectrum of surgical and medical conditions.
“There are significant challenges with conventional IV opioids in striking the balance between finding effective pain relief and minimizing treatment-limiting side effects,” said Harold S. Minkowitz, M.D., Associate Director, Clinical Research, Division of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Centre. “There have been very few new analgesic options in decades. The data from this study suggests that oliceridine, if approved, may be an important new treatment option in lieu of conventional IV opioids.”
Poster presentation: Sunday, October 14th
- e-poster presentation (A2174): Athena: A Phase 3, Open-label Safety Study of Oliceridine for the Treatment of Moderate-to-severe Acute Pain. Scheduled to be presented on Sunday, October 14th from 10:00 – 10:30 am on Monitor #02 in the Convention Center room, North, Hall D, Area A, at the Moscone Center.
In the ATHENA open-label safety study, oliceridine was administered to 768 patients with moderate to severe acute pain caused by medical conditions or surgery across 41 sites in the United States. The trial included substantial representation of patients at elevated risk for opioid-related adverse events (ORAEs), with 32% of patients over 65 years old, and more than 50% with body mass index (BMI) over 30 kg/m2. Results of the trial showed that the safety profile of oliceridine, in a broader patient group, is like that demonstrated in the controlled Phase 2 and 3 studies of oliceridine.
Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of new and innovative treatment options for patients in pain. The Company has discovered three novel and differentiated drug candidates using its proprietary platform, including intravenous (IV) oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for pain and/or management of opioid dependence. In its preclinical programs, Trevena is evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain.
Cautionary note on 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 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 or any future trials, including whether the data from the ATHENA open-label safety study suggest that oliceridine, if approved, may be an important new treatment option in lieu of conventional opioids; the uncertainties inherent in conducting clinical trials; interpretations of regulatory interactions and expectations for regulatory submissions and 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; 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.
Senior Vice President, Scientific Affairs & Investor Relations Officer
Released October 12, 2018