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FDA Advisory Committee recommends approval of long-acting buprenorphine

Braeburn Pharmaceuticals recently announced the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 to recommend approval of CAM2038, an investigational weekly and monthly buprenorphine depot injection, for treatment of opioid use disorder in adults.

The advisory committee’s decision was based on a review of a clinical trial program that included seven phase 1 to 3 clinical trials, of which one was a long-term safety study, among patients with opioid use disorder.

In September 2017, CAM2038 was accepted under priority review designation by the FDA.

The FDA set a Prescription Drug User Fee Act target date of January 19, 2018.

“The panel’s recommendation in favor of CAM2038 brings us another step closer to providing an individualized treatment option to support [opioid use disorder] patients from day one of their recovery, through initiation, to longer-term maintenance therapy,” Michael M. Derkacz, president and CEO of Braeburn, said in a press release. “The magnitude of the opioid crisis noted in the President’s Commission report reinforces the need for new, medication assisted therapies such as CAM2038, which is administered by health care professionals ensuring medication adherence, while potentially minimizing risks of diversion, abuse, misuse and accidental pediatric exposure.”