Swedish research-based pharmaceutical and biotechnology company Camurus has received European Commission (EC) approval for weekly and monthly Buvidal injections to treat opioid dependency in adults and teenagers from 16 years of age.
Buvidal is the first long-acting medicine to have received EU approval for the treatment the problem of opioid dependency.
It is a lipid-based solution formulated with Camurus’ FluidCrystal injection depot technology. Once injected, it transforms into a gel-like depot.
The depot gradually biodegrades and then releases buprenorphine, which not only stops the drug-like effect of opioids in the brain but also reduces cravings for opioids.
UK-based Kings College’s National Addiction Centre director 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.”
Camurus president and CEO Dr Fredrik Tiberg said: “The 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 is considered to be a major milestone for the company.
Tiberg added: “Our first long-acting medicine validates our FluidCrystal technology, which is the foundation of our extensive development pipeline of new drug candidates.”
EC approval for Buvidal is based on safety and efficacy data drawn from a global development programme consisting of seven clinical studies, including a randomised, double-blind, double-dummy, active-controlled Phase 3 study on 428 patients with opioid dependence.
Results from the trial indicated that Buvidal offered improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.
Buvidal (CAM2038) is currently being reviewed for marketing authorisation in Australia and the US. The US Food and Drug Administration (FDA) has issued a PDUFA goal date of 26 December 2018 for Buvidal to the firm’s US partner Braeburn.