CHMP recommends approval of Buvidal slow release injection for opioid dependence.- Camurus

Camurus announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has issued a positive opinion recommending marketing authorization for a new, 160mg, monthly dose of Buvidal (buprenorphine) prolonged release injection for the treatment opioid dependence in adults and adolescents from 16 years of age. Buvidal is the first long-acting injectable treatment of opioid dependence approved in the EU and offering patients the flexibility of multiple weekly and monthly dosing options as an alternative to daily administered medications. Buvidal has in randomised controlled clinical trials demonstrated superior treatment effect and better patient reported outcomes, including treatment satisfaction, reduced burden of treatment, and quality of life of patients compared to daily sublingual buprenorphine. The marketing authorisation for the new 160mg Buvidal dose is expected from the European Commission in the end of May 2021.