Trevena, Inc. 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. 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. About TRV734: TRV734 is an orally available new chemical entity that targets the mu-opioid receptor with a novel mechanism of action, which selectively stimulates G-protein signaling with low beta-arrestin recruitment. In preclinical studies, TRV734 demonstrated similar analgesic effect with less constipation compared to equivalently analgesic doses of oxycodone and morphine. Trevena is collaborating with NIDA to further evaluate TRV734 as a potential maintenance therapy for opioid use disorder. TRV734 is an investigational product not approved by FDA for distribution in the US.