- Camurus (OTC:CAMRF) announces 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, Phase 3 study in 428 patients with opioid dependence.
- CAM2038 is also under review for marketing authorization in Australia and the US. The FDA has issued a PDUFA goal date of 26 December 2018 for CAM2038 to Camurus' US partner Braeburn.