Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Braeburn Pharmaceuticals and Camurus announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the CAM2038 weekly and monthly buprenorphine subcutaneous injection products under development for the treatment of opioid addiction.

"The CAM2038 suite of products offers a potential paradigm shift for treating opioid addiction: precise delivery of medicine while virtually eliminating the risks of diversion, abuse, misuse, and accidental pediatric exposure," said Behshad Sheldon, President and CEO, Braeburn Pharmaceuticals. "The sense of urgency to address the opioid epidemic in our country is overwhelming. Granting fast track to the CAM2038 development program demonstrates the FDA's recognition of the unmet need in this area as well as the agency's leadership in enabling new opportunities to stem the tide of opioid addiction."

Last year, Camurus and Braeburn entered into an agreement that gives Braeburn exclusive license rights in North America to CAM2038 products as treatments for opioid addiction and pain. The weekly and monthly CAM2038 injectable buprenorphine products have been evaluated, thus far, in 176 healthy volunteers and patients in three shorter-term clinical trials demonstrating a promising drug release, safety, and tolerability profile.

"CAM2038 is designed to be conveniently administered by healthcare 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," said Fredrik Tiberg, President and CEO, Camurus. "The flexibility of multi-dose, weekly and monthly injections also enables personalized medication during all stages of the buprenorphine treatment continuum."

Braeburn and Camurus also announced today that the first patient has been dosed in a Phase 2 study designed to assess the effectiveness of CAM2038 in blocking the effects of other opioids. Braeburn and Camurus have worked closely with the FDA on the design of this study intended to provide important insight into CAM2038's ability to block the effects of other opioids, ultimately supporting future regulatory submissions.

The results of this multi-site study are expected to provide guidance about optimizing individualized treatment for these patients, including during early stages of recovery.

"These long-acting formulations have the potential to change the delivery of opioid dependence treatment in the U.S. by decreasing the burdens for patients and physicians and decreasing the risks of buprenorphine diversion," said Dr. Sharon Walsh, principal investigator at the University of Kentucky. "This study is an important step in the development of these potentially transformative buprenorphine products in the treatment for opioid dependence."

"The CAM2038 products are part of our vision to address some of the important roadblocks to recovery that seem inherent in current treatment options for opioid addiction," said Sheldon. "By offering pill-free solutions that administer treatment through innovative delivery systems, we believe we can dramatically improve patient outcomes, and even help to save and rebuild lives. We are committed to this important work, and will be striving to complete this study as expeditiously as possible, and to initiate our Phase 3 program by year end."