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Phase III trial for injectable opioid dependence treatment succeeds

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Braeburn Pharmaceuticals and Camurus report that a late-stage trial of weekly and monthly injections of buprenorphine (CAM2038) to treat moderate-to-severe opioid use disorder met FDA and EMA primary endpoints of non-inferiority. The Phase III study involved 428 patients with opioid use disorder.

Braeburn Pharmaceuticals and Camurus report that a late-stage trial of weekly and monthly injections of buprenorphine (CAM2038) to treat moderate-to-severe opioid use disorder met FDA and EMA primary endpoints of non-inferiority. The Phase III study involved 428 patients with opioid use disorder. According to the data, CAM2038 achieved the primary objective of statistical non-inferiority compared with daily sublingual buprenorphine/naloxone, the current standard of care, for both FDA and EMA's specified endpoints of responder rate and percent negative urine samples for opioids. Camurus president and CEO Fredrik Tiberg said the findings "provide strong support for our upcoming market authorization applications." The two companies will work with FDA and EMA to start the submission process. FDA has granted fast-track designation for CAM2038 subcutaneous injectable products to treat opioid addiction.

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http://clinicaltrials.pharmaceutical-business-review.com/news/braeburn-says-phase-3-trial-for-injectable-opioid-dependence-treatment-succeeds-5669043

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