Braeburn Pharmaceuticals said today that the FDA granted priority review to the company’s CAM2038 NDA. The investigational weekly and monthly buprenorphine depot injection was designed to treat adults with opioid use disorder.
The regulatory agency is slated to make a decision about CAM2038 by January 10, 2018.
“FDA’s acceptance of our NDA for CAM2038 under priority review represents an important step in advancing Braeburn’s mission to provide opioid use disorder patients with effective treatment options which can be individualized to support them throughout their recovery – from initiation and stabilization, to longer-term maintenance,” president & CEO Mike Derkacz said in prepared remarks. “Because the weekly and monthly formulations are administered by healthcare professionals and remain in their control, if approved, CAM2038 may help mitigate the inherent risks of daily oral medication in terms of diversion, misuse and pediatric exposure.”
The subcutaneous injection is set to be offered in dosage strengths for once-weekly and once-monthly administration in prefilled syringes.
CAM2038’s NDA included positive results from a pivotal Phase III trial, demonstrating non-inferiority versus treatment with the current standard of care – a daily sublingual buprenorphine/naloxone product.
Braeburn’s depot also had a safety profile that was consistent with the known safety profile of buprenorphine, except for some mild-to-moderate adverse events at the injection site.
Researchers have evaluated CAM2038 in seven clinical trials, as well as a long-term safety study, Braeburn reported.