LUND, Sweden, September 18, 2017 /PRNewswire/ --
The FDA has assigned a PDUFA target date of January 19, 2018
Camurus announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for weekly and monthly CAM2038 buprenorphine depots for the treatment of adults with opioid use disorder (OUD) and granted a Priority Review. The NDA for CAM2038 was submitted on July 19, 2017 by Camurus' U.S. partner Braeburn Pharmaceuticals and comprises data from seven clinical trials, including two Phase 3 trials.
"The FDA's grant of Priority Review signifies the Agency's view that our weekly and monthly buprenorphine depots, if approved, would be significant improvements in the safety or effectiveness of the treatment of opioid use disorder when compared to standard treatments," said Fredrik Tiberg, President and CEO of Camurus. "With this milestone, we are one step closer to our goal of bringing new, effective and individualized treatment alternatives to the many millions of people living with opioid use disorder."
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 opioid use disorder. In addition to achieving the primary endpoint (treatment 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 for 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.
The FDA will convene an Advisory Committee meeting for CAM2038 in Q4, 2017. Additionally, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 19, 2018.
For more information about CAM2038, please see the full press release at http://www.camurus.com.
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 08.00 am CET on 18 September 2017.