Camurus announces submission of request for final approval of Brixadi™ for the treatment of opioid use disorder in the US
Lund, Sweden — 1 June 2020 — Camurus AB (NASDAQ STO: CAMX) today announces that the company’s US partner Braeburn has submitted a request for final approval of Brixadi™ (buprenorphine) weekly and monthly extended release injection for the treatment of opioid use disorder to the US Food and Drug Administration (FDA). On 21 December 2018, Brixadi (the US trade name for Buvidal[®]) was tentatively approved by the FDA, having met all regulatory requirements regarding efficacy, safety and quality. However, Brixadi was not eligible for marketing in the US because of an exclusivity period