Braeburn Pharmaceuticals, an Apple Tree Partners company and a pill-free pharmaceutical company, and Camurus, a Swedish research-based pharmaceutical company, announced that the first patient has been randomized in the double blind phase 3 efficacy trial of CAM2038 in opioid-dependent patients. CAM2038 medications are designed for long-acting weekly and monthly administration. This randomized, double blind, active-controlled phase 3 trial is part of the registration programme for CAM2038, which also includes two additional trials that were recently started; a phase 2 opioid blockade study and a long-term safety trial.

“We know through evidence-based research that long-term outpatient use of buprenorphine is essential in the treatment of opioid dependence. CAM2038 represents a novel approach, allowing personalized treatment with the potential to eliminate many of the challenges associated with current buprenorphine medications, and take this treatment to a new level,” said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals.

“With all three pivotal registration studies of CAM2038 for opioid dependence moving forward, we’re now closer to delivering results that could have a real impact on the lives of people with opioid addiction and their families.”

Over the past decade, opioid addiction has become an epidemic in the US, yet it is under-recognized and few medicines are in development for its treatment. A chronic, relapsing disease, opioid addiction can lead to overdose and death. The Center for Disease Control and Prevention (CDC) recently reported that opioid-related overdose deaths hit a record high in the US of almost 29,000 in 2014, corresponding to nearly 80 deaths each day.

“The success of this trial has the potential to bring a paradigm shift in the way people with opioid dependence are treated,” said Dr. Rishi Kakar, Segal Institute, Florida. “CAM2038 will give physicians the ability to specialize treatment based on patients’ needs and goals by providing both monthly and weekly dosing options.”

“This pivotal phase 3 study will provide essential insights about the use and potential of our long-acting CAM2038 medications in helping opioid-dependent patients to manage their disease more effectively,” said Fredrik Tiberg, president and CEO of Camurus.

“We see a great deal of interest in the CAM2038 development program globally, from both patients and health care providers, and look forward to an expeditious enrollment and completion of the study during the second half of 2016.

The investigational CAM2038 buprenorphine subcutaneous injection products for treatment of opioid addiction are being developed as once-weekly and once-monthly formulations, each with multiple doses, to cover all phases of treatment from initiation through maintenance.  The CAM2038 products are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion, abuse, misuse, and accidental exposure. The CAM2038 products have been evaluated in three phase 1/2 clinical trials, which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of 176 individuals (opioid-dependent patients and healthy volunteers under naltrexone blockage).