received approval

Europe has seen its first and only approval of a long-acting therapy for opioid dependence, as the European Commission (EC) confirms the marketing authorisation of Camurus’ Buvidal (CAM2038).

The injectable drug has received approval for the treatment of opioid dependence within a framework of medical, social and psychological treatment in patients older than 16.

"Patients with opioid dependence in Europe are in great need of new and more effective medications that can improve treatment outcomes and quality of life," commented Professor Sir John Strang, Director of the National Addiction Centre, King’s College, London. "Buvidal weekly and monthly subcutaneous injection depots could become a game-changer in opioid dependence treatment by improving adherence and reducing the burden, stigma and risks of daily treatment."

The EC based its decision on data drawn from seven Phase 1-3 trials. As the manufacturer noted, Phase 3 data demonstrated that Buvidal proved at least as effective as standard treatment with daily buprenorphine/naloxone.

Camurus President & CEO Fredrik Tiberg also remarked: "The marketing authorisation of Buvidal is a significant step forward in addressing the substantial unmet need in opioid dependence by delivering a new, long-acting and flexible treatment option. We are committed to making Buvidal available for patients as soon as possible, with the initial wave of country launches scheduled for the first quarter of 2019. This approval represents a major milestone for the company. Our first long-acting medicine validates our FluidCrystal technology which is the foundation of our extensive development pipeline of new drug candidates."

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