Trevena Announces NIH Has Resumed Recruiting Patients in Proof-of-Concept Study for TRV734 in Opioid Use Disorder
June 16, 2021 at 07:00 am
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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.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of medicines for patients with central nervous system (CNS) disorders. The Company has one approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Companyâs pipeline includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder. TRV045 is a novel, highly selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. TRV734 is a small molecule G-protein biased ligand of the mu opioid receptor (MOR).