Benzinga | Jun 16, 2021 07:03AM EDT

Trevena Announces NIH Has Resumed Recruiting Patients In Proof-Of-Concept Study For TRV734 In Opioid Use Disorder

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 that NIDA has resumed recruiting patients for its proof-of-concept study for TRV734, the Company's novel mu-opioid receptor selective agonist. The Company has an ongoing collaboration with NIDA to evaluate TRV734 as a potential maintenance therapy for opioid use disorder (OUD). The study was paused in March 2020 due to the global COVID-19 pandemic.

"Opioid use disorder remains an urgent public health issue -- even as COVID-19 remains front of mind. It is important that the development of effective treatments for patients with opioid addiction continues," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "NIDA's resumption of their study for TRV734, which may offer an effective treatment option with improved tolerability compared to current standard of care, underscores the unmet need for treatments for OUD. With this collaboration, we continue to build upon a robust partnership with NIH to explore several of our pipeline assets."

The NIDA study of TRV734 marks the third investigational drug product within Trevena's pipeline being researched by the NIH. This is a randomized, double-blind, four-period, placebo- and positive-controlled study that will enroll approximately 50 opioid-dependent patients undergoing stable methadone maintenance therapy. The primary outcome is suppression of withdrawal symptoms as measured by the Subjective Opioid Withdrawal Scale. The study will also evaluate whether TRV734 suppresses withdrawal signs using the Clinical Opioid Withdrawal Scale. Secondary outcomes will include assessments of safety, tolerability, and measures of neurocognitive changes.