Camurus Receives EU Approval for Weekly and Monthly Buvidal

Camurus announced 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.

"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," said 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."

Formulated with Camurus' proprietary FluidCrystal injection depot technology, Buvidal is a lipid-based solution which, once injected, transforms into a gel-like depot. The depot slowly biodegrades over time, releasing the buprenorphine which blocks the drug-liking effect of opioids in the brain and reduces withdrawal, craving and patient's use of illicit opioids.

"Today's approval of Buvidal provides an innovative and much-needed new treatment option to the more than half a million people with opioid dependence in Europe who are currently receiving daily medication. 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," said Dr. Fredrik Tiberg, President and CEO of Camurus. "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."

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, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. Results from this study demonstrated that Buvidal provided improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.

CAM2038 is also under review for marketing authorization in Australia and the US. The US Food and Drug Administration (FDA) has issued a PDUFA goal date of 26 December 2018 for CAM2038 to Camurus' US partner Braeburn.

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