Injectable buprenorphine moves closer to approval

Prospects for the market arrival of a monthly formulation of buprenorphine to combat opioid addiction have further improved with this week's announcement that a federal advisory panel has recommended the approval of Indivior's RBP-6000 drug.

Reuters reported that the advisory committee to the Food and Drug Administration (FDA) voted 18-1 to recommend the approval. The lower of two doses examined in the manufacturer's latest research caused fewer side effects, though some panel members expressed a preference for making both dosing schedules available. The FDA is expected to issue an approval decision on the drug by the end of this month.

The companies Camurus and Braeburn Pharmaceuticals also are awaiting FDA action on their injectable buprenorphine product CAM2038, at a time when federal officials are seeking to facilitate greater use of medication treatment to combat the opioid crisis.

Indivior, which also markets a buprenorphine-naloxone film product, found in its research little difference in outcome between an RBP-6000 dosing regimen of 300 mg monthly for six months and a regimen of two 300-mg doses followed by four 100-mg doses.

Based on the convenience of monthly dosing, one analyst who was cited in the Reuters article believes RBP-6000 could capture 30% of the buprenorphine market.