Camurus: FDA tentative OK of extended-release med for opioid abuse

Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) has issued Camurus’ US partner Braeburn a tentative approval of Brixadi™ (buprenorphine) extended-release injection for subcutaneous use, 8 mg, 16 mg, 24 mg, 32 mg (weekly) and 64 mg, 96 mg, 128 mg (monthly). The tentative approval is for use of Brixadi for the treatment of moderate-to-severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublocade™. The restriction period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged.

https://www.marketscreener.com/CAMURUS-AB-26287784/news/Camurus-US-FDA-issues-a-tentative-approval-of-Brixadi-trade-buprenorphine-extended-release-inje-27793426/