Camurus gets EU nod for weekly and monthly Buvidal for opioid dependence

This marks the first approval of a long-acting treatment for opioid dependence in the EU.

London’s King’s College National Addiction Centre director professor Sir John Strang, 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.”

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.

Camurus president and CEO Dr Fredrik Tiberg said: “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.

“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.

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. [2]

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.

The EC decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 21 September 2018, recommending approval of Buvidal.

This allows for marketing of Buvidal in all 28 member states of the EU, and the European Economic Area countries Norway, Iceland and Liechtenstein.

Opioid dependence is a serious, chronic, relapsing disease that can affect all aspects of a person’s daily life.

It is an escalating global health problem, contributing to significant adverse mental, physical, and social consequences, including unemployment, criminal activity, incarceration, transmission of infectious diseases, unintentional overdose and death.

According to the World Drug Report, approximately 34 million individuals globally use opioids for non-medical purposes and an estimated 127,000 people die each year from opioid overdoses. Opioids top the list of drugs that cause the greatest burden of disease and drug-related deaths worldwide.

Source: Company Press Release