The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for Buvidal (buprenorphine) in a prolonged-release solution for injection.
Buvidal was recommended for approval for the treatment of opioid dependence in adults and adolescents over 16 years of age.
According to the World Drug Report the global approximate number of individuals using opioids for nonmedical purposes is currently 33 million.
It is administered in weekly and monthly injections by healthcare professionals at clinics developed for the treatment of opioid dependence. The prolonged-release design aims to reduce misuse and provide adherence to the treatment plan.
CHMP based its approval opinion on a comprehensive clinical program with seven clinical studies. One of these studies was a randomized, double-blind, double-dummy, active-controlled Phase III study in 428 participants. All of the participants in the Phase III study had opioid dependence.
The study’s results showed that Buvidal improved treatment outcomes when compared to the standard treatment of sublingual buprenorphine/naloxone.
The drug is currently under regulatory review for approval in the US and Australia. Camurus’ partner Braeburn will be responsible for the regulatory procedure in the US.
The final decision on Buvidal will be decided by the European Commission in late November 2018.