FDA Declines to Approve Braeburn Opioid Use Disorder Treatment

Complete response letter seeks more information on CAM2038

The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD).

The FDA has requested additional information in order to move the application forward. “There is no need for additional clinical studies and the agency's requests will be addressed in a timely manner,” said Braeburn, which did not otherwise specify the information the agency is seeking.

"Braeburn will continue to work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible," added Mike Derkacz, President and CEO of Braeburn.

CAM2038 was previously granted fast track and priority review designations by the FDA. If approved, CAM2038 would be the first and only injectable for OUD that can be administered by health care professionals from day 1 of a patient's OUD treatment.

In 2016, roughly 11.6 million adults misused opioids in the U.S., but only 1.1 million received medication assisted therapy, according to the Substance Abuse and Mental Health Services Administration. Opioid overdose is now the leading cause of death among people under the age of 50 in the U.S.

CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by health care professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure.

CAM2038 has been evaluated in seven phase 1 to 3 clinical trials, including a pivotal phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.

Source: Braeburn; January 21, 2018.