The US Food & Drug Administration's drugs advisory committee and drug safety and risk management advisory committee voted 18 to 1 to recommend approval of Indivior's RBP-6000, which was largely as expected.

Indivior, which has worked closely with the FDA on the final stages of development of RBP-6000, has produced a once-monthly injectable buprenorphine formulation using the 'Atrigel' delivery system to treat adults with moderate-to-severe opioid use disorder, as part of a complete treatment plan to include counselling and psycho-social support.

The FDA will consider the advisory committees' non-binding recommendation in its review of the new drug application for RBP-6000 that Invidior submitted in May.

The FDA has set a deadline of 30 November.