Camurus has announced that the European Commission has granted marketing authorisation for Buvidal.
Buvidal® (CAM2038), the first and only long-acting injectable treatment available in both weekly and monthly formulations in the EU, that is indicated for the treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents aged 16 years or over.
Opioid dependence is a chronic, relapsing brain disease that involves a physical and psychological need for opioids that causes major medical, social and economic problems to both the individual and society. Similar to other chronic diseases, like type 2 diabetes, hypertension and asthma, opioid dependence often involves cycles of relapse and remission and has comparable relapse rates. In the UK, over 330,000 high-risk users are injecting or using opioids regularly, with less than half receiving medical treatment. The latest figures show the number of people dying from opioid-related drug misuse has reached a record high in England and Wales, with almost 9 in 10 drug-related deaths involving an opioid.
Buvidal® offers a treatment that can be individualised to specific patient needs due to flexible, weekly and monthly doses that allows for dose conversion from sublingual buprenorphine, can improve treatment outcomes and reduce the burden, risks and stigma of daily dosing. Formulated with Camurus’ proprietary FluidCrystal® injection depot technology, Buvidal® is an innovative 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.
European Commission has also granted marketing authorisation toYescarta for the treatment of blood cancer while Xeljanz received marketing authorisation for psoriatic arthritis and BRAFTOVI® and MEKTOVI® was granted this authorisation for melanoma treatment.
Fredrik Tiberg, President & CEO of Camurus said, “The marketing authorisation for 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.”
Professor Sir John Strang, Director of the National Addiction Centre, King’s College, London said, “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. 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 marketing authorisation for Buvidal is based on a comprehensive clinical programme of seven Phase 1-3 clinical trials demonstrating that Buvidal® delivers clinically proven rapid, predictable and sustained release of buprenorphine over a week or month. In the pivotal Phase 3 study, Buvidal® was shown to be at least as effective as standard treatment with daily buprenorphine / naloxone for the primary endpoint of the mean percent urine tests negative for illicit opioids (p<0.001). Superior treatment effect was demonstrated for the key secondary endpoint of cumulative distribution function for the percent urine tests negative for illicit opioid use (p=0.008). The safety profile of Buvidal was comparable to daily SL BPX, except for mild to moderate injection site reactions. The most common side effects of Buvidal® are headache, nausea, hyperhidrosis, insomnia and mild-to-moderate injection-site reactions.