The US Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee has voted 18 to 1 to recommend approval of an investigational drug for the treatment of opioid use disorder (OUD).
RBP-6000 (Indivior PLC) is a once-monthly injectable formulation of buprenorphine that uses the Atrigel delivery system for the treatment of adults with moderate to severe OUD as part of a complete treatment plan that includes counseling and psychosocial support, the company said in a news release.
The phase 3 study of RBP-6000 met its primary efficacy endpoint, with both doses tested demonstrating significantly higher abstinence rates vs placebo (P < .0001). RBP-6000 was generally well tolerated; its safety profile was consistent with that of transmucosal buprenorphine except for injection site reactions.
The most common adverse reactions (reported in ≥5% of patients) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzyme, fatigue, and injection site pain.
“The advisory committees’ favorable recommendation of RBP-6000 moves us one step closer to potentially bringing this once-monthly injectable buprenorphine treatment option to patients struggling with opioid use disorder,” said Shaun Thaxter, Indivior’s chief executive officer, in the release.
The FDA is expected to make a decision on RBP-6000 by November 30.
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