Posted by Michael Wonder on 23 Nov 2018
Camurus receives EU approval for weekly and monthly Buvidal (CAM2038) for opioid dependence
22 November 2018 - Buvidal is the first long-acting medicine approved in the EU for the treatment of opioid dependence in adults and adolescents.
Camurus announced today that the European Commission (EC) has approved weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age. This marks the first approval of a long-acting treatment for opioid dependence in the EU.
The EC approval of Buvidal is based on safety and efficacy data from a comprehensive global development program comprising seven clinical studies, including a randomized, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. Results from this study demonstrated that Buvidal provided improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.
