Camurus announced today that 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,” says 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. [1-4]
“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,” says 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,” he adds.