Opiant Pharmaceuticals said that it has initiated a Phase 2 trial of its OPNT002 intranasal naltrexone for the treatment of alcohol use disorder that is expected to enroll approximately 300 patients, with results expected in 2023. The study will evaluate the efficacy of OPNT002 by measuring improvement in WHO drinking risk level.
OPNT002 is formulated with Intravail absorption enhancer, which Opiant licensed from Aegis Therapeutics in 2017 prior to Aegis’s acquisition by Neurelis. In 2017, Opiant announced that a Phase 1 trial of OPNT002 demonstrated a significant decrease in the time to reach Tmax and a significant increase in Cmax for OPNT002 compared to an intranasal formulation of naltrexone without an absorption enhancer.
CEO Roger Crystal commented, “Multiple medications are approved for the treatment of AUD, yet less than 10% of individuals with AUD currently receive treatment. For those suffering from AUD, current therapies and treatments are built around an endpoint of abstinence, rather than harm reduction. The availability of a treatment option in the event a person craves alcohol, anticipates drinking or finds themselves in a high-risk situation such as a party or restaurant setting is an approach we believe could increase the number of people using medication.”
Read the Opiant Pharmaceuticals press release.
