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United States : FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder.

Braeburn Pharmaceuticals, Inc. (Braeburn) announces that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) with Priority Review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The NDA for CAM2038, which was submitted on July 19, 2017, comprises data from five Phase 1-2 clinical trials as well as two Phase 3 trials.

FDAs acceptance of our NDA for CAM2038 under Priority Review represents an important step in advancing Braeburns 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, said Mike Derkacz, President and CEO of Braeburn. 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.

A core component of the NDA submission is the positive results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) in patients with OUD. This study enrolled a wide OUD population including patients who had concomitant use of other non-opioid substances of abuse, such as amphetamines, cocaine, marijuana, and benzodiazepines. The study also initiated treatment immediately without a need for any prior induction period. In addition to achieving the primary endpoint (response rate) of non-inferiority versus treatment with daily sublingual buprenorphine/naloxone, the current standard of care, CAM2038 also demonstrated superior treatment effect for the secondary endpoint (Cumulative Distribution Function of the percentage of urine toxicology negative for illicit opioids confirmed by self-report). 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.

FDA has granted Fast Track and Priority Review designations for CAM2038 buprenorphine weekly and monthly depot for the treatment of opioid use disorder and will convene an Advisory Committee meeting for CAM2038 in Q4 2017. Additionally, FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 19, 2018.

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Publication:Mena Report
Date:Sep 21, 2017
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