Indivior (LON:INDV) said today that the FDA’s psychopharmacologic drugs advisory committee and drug safety and risk management advisory committee voted 18-1 recommending approval of the company’s once-monthly injectable treatment for opioid use disorder.
The company’s RBP-6000 treatment is designed for adults with moderate-to-severe opioid use disorder. The FDA is slated to make a decision about Indivior’s product by the end of November.
“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,” CEO Shaun Thaxter said in prepared remarks. “We are committed to pioneering new options for patients living with this chronic, yet treatable disease to help address the nation’s growing opioid epidemic.”
In July, the FDA granted priority review designation to the company’s RBP-6000 NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy of RBP-6000.
The therapy would be the first once-monthly buprenorphine injection treatment for opioid use disorder, if it wins approval by the FDA. The depot formulation is delivered by healthcare professionals using Indivior’s Artigel delivery system and is designed to make abuse and diversion of the drug challenging.