Trevena Announces Publication of Comprehensive Review of Oliceridine Data

Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients

CHESTERBROOK, Pa., April 23, 2020 (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 the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today.

The publication is titled “Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain”, with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony Brook Medicine (DOI: 10.1358/dot.2020.56.4.3107707).

“I am pleased to have the opportunity to provide a comprehensive overview of the data we have amassed over the entire oliceridine development program from over 1,800 individuals,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. “This monograph is the latest addition to the compelling body of peer-reviewed published literature for oliceridine, and summarizes the novel characteristics that make it a potentially differentiated treatment option for moderate-to-severe acute pain in hospital settings.”

Monograph Key Points:

• Novel, biased mechanism of action; robust efficacy in animal models with less associated constipation, gastrointestinal (GI) dysfunction, and respiratory depression.
  
  
• Novel pharmacology with a half-life that allows for adequate drug concentrations to provide efficacy without drug accumulation or development of active metabolites. No dosage adjustments needed when administering oliceridine to patients with renal impairment, mild to moderate hepatic impairment, or the elderly.
  
  
• Rapid analgesia in hard- and soft-tissue surgeries in patients with moderate-to-severe acute pain. Safe and well-tolerated in a large, open-label, “real world” safety study, including in high-risk patients with advanced age, obesity, and diabetes and across a variety of surgical procedures and settings of care.

About Oliceridine
Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous 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 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 disorders. 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 treating a variety of CNS disorders.

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 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 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 FDA, the timing of FDA’s decision on the oliceridine NDA; available funding ; 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:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
(617) 430-7576

Company Contact:
Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840

Released April 23, 2020