FDA grants fast track designation to weekly, monthly injections for opioid addiction

Braeburn Pharmaceuticals and Camurus recently announced that the FDA granted fast track designation for the CAM2038 buprenorphine subcutaneous injection products for treatment of opioid addiction.

Camurus and Braeburn Pharmaceuticals entered into an agreement in 2014 to give Braeburn exclusive license rights in North America for CAM2038 products and treatments for opioid addiction and pain, according to a press release.

Three short-term clinical trials among 176 healthy volunteers and patients have indicated promising drug release, safety and tolerability of the weekly and monthly buprenorphine products.

“CAM2038 is designed to be conveniently administered by health care professionals. By eliminating the need for daily dosing, CAM2038 has the potential to improve medication adherence and help patients avoid relapse, a critical aspect of a comprehensive approach to treating opioid addiction,” Fredrik Tiberg, MSc, PhD, president and CEO of Camurus, said in the release. “The flexibility of multidose, weekly and monthly injections also enables personalized medication during all stages of the buprenorphine treatment continuum.”

Sharon Walsh

Braeburn and Camurus have also announced that the first patient has been dosed for a phase 2 study assessing efficacy of CAM20138 for blocking the effects of other opioids. Results from this study may help develop guidance on optimizing individualized treatment during the early stages of recovery.

“These long-acting formulations have the potential to change the delivery of opioid dependence treatment in the United States by decreasing the burdens for patients and physicians and decreasing the risks of buprenorphine diversion,” study researcher Sharon Walsh, PhD, of the University of Kentucky, said in the release. “This study is an important step in the development of these potentially transformative buprenorphine products in the treatment for opioid dependence.”