Posted by Michael Wonder on 30 Nov 2021
The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain
30 November 2021 - Camurus today announces that the EMA has accepted the company’s submission of a Type II variation application for Buvidal (buprenorphine) prolonged release injection to include treatment of chronic pain.
The regulatory submission is supported by results from a Phase 2 study of Buvidal (CAM2038) in patients with chronic non-cancer pain and opioid dependence, and a Phase 3 efficacy and safety study of CAM2038 in patients with moderate to severe chronic low back pain treated with opioid pain medications for a minimum of 3 months prior to study enrollment.
