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 — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, 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.”

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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.

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.

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