CHESTERBROOK, Pa., Oct. 21, 2019 (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) conditions, today announced four presentations at ANESTHESIOLOGY® 2019, the national conference for the American Society of Anesthesiologists, held at the Orange County Convention Center in Orlando, Florida, October 19-23. The presentations included one oral presentation and three posters, all of which discussed the safety profile of oliceridine.
“IV opioids remain an effective treatment option for physicians in managing moderate-to-severe acute pain following surgery. However, opioid-related adverse effects – most notably respiratory depression – can interfere with a drug’s analgesic efficacy and complicate a patient’s recovery,” said Albert Dahan, M.D., Professor of Anesthesiology at the Leiden University Medical Center. “Because there are no generally agreed standard definitions for respiratory depression, our group has devoted attention to improving the quantitative assessment of respiratory depression in controlled clinical settings for various opioid medications. We applied this technique, called clinical utility function analysis, to available data for oliceridine, and I was pleased to present the intriguing results of that analysis at this year’s conference.”
Dr. Dahan presented the findings from a clinical utility function analysis of the ventilatory response to hypercapnia data from the Phase 1 proof-of-concept study comparing oliceridine to IV morphine in healthy human volunteers. The oral presentation, titled “Improved safety of opioid analgesic Oliceridine compared to Morphine assessed by utility function analysis,” was part of the Best of Abstracts: Clinical Science featured session.
In addition, three poster presentations featured safety and tolerability data from the Phase 3 pivotal trials (APOLLO 1 / APOLLO 2) and “real-world use” open-label safety study (ATHENA) for oliceridine:
- Low Incidence Of Opioid-induced Respiratory Depression Observed With Oliceridine Regardless Of Age Or Body Mass Index (Brzezinski, M. et al) (e-poster, abstract #2228)
- Lower Incidence Of Postoperative Opioid-induced Respiratory Depression With Oliceridine Compared To Morphine: A Retrospective Analysis (Bergese, S. et al) (e-poster, abstract #2232)
- Oliceridine (TRV130) Demonstrates Less Opioid-induced Respiratory Depression Than Morphine (M) As Measured By The Average Cumulative Duration Of Dosing Interruption In Patients Being Treated For Acute Post-surgical Pain (Ayad, S. et al) (e-poster, abstract #3069)
About Oliceridine
Oliceridine is a G protein biased (selective) mu-opioid receptor (MOR) ligand in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings 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 expects that oliceridine will be classified as a Schedule II controlled substance.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS conditions. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.
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, nonclinical studies, or any future trials, including with respect to any future clinical study of oliceridine; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with FDA, and whether there is a path to resubmit the oliceridine NDA; 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.
For more information, please contact:
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: IR@trevena.com
Company Contact:
Bob Yoder, SVP and Chief Business Officer
Trevena, Inc.
Phone: 610-354-8840