- CAM2038 met Both FDA and EMA Primary Endpoints of Non-inferiority (p<0.001)
- CAM2038 Demonstrated Statistical Superiority for the Key Secondary Endpoint (p=0.004)
- Robust Clinical Data to Support MAA and NDA Submissions in mid-2017
Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) announce positive top-line results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate-to-severe opioid use disorder. In addition to achieving the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care, SL BPN/NX), CAM2038 also demonstrated superiority for the key secondary endpoint.
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"The positive results of this pivotal head-to-head Phase 3 study represent an important breakthrough for our weekly and monthly CAM2038 products for treatment of opioid dependence, as well as a confirmation of the strength and applicability of our proprietary FluidCrystal® technologies and pipeline," said Dr. Fredrik Tiberg, President and CEO of Camurus. "The results of this rigorous evaluation of CAM2038 compared to standard of care provide strong support for our upcoming market authorization applications."
In the Phase 3 study enrolling 428 patients with opioid use disorder, CAM2038 achieved the main objective of statistical non-inferiority compared to the active comparator of SL BPN/NX for both the FDA and the EMA specified endpoints of responder rate (RR) (CI -3.5%, 10.4%; p<0.001) and percent negative urine samples for opioids (CI -0.2%, 13.7%; p<0.001), respectively.
Importantly, while this Phase 3 study was designed and powered for assessing non-inferiority, the protocol also planned to test superiority against SL BPN/NX based on the pre-defined secondary endpoint of cumulative distribution function (CDF) of the percent urines negative for opioids combined with self-reports for weeks 5 through 24. The superiority of CAM2038 over SL BPN/NX was established with p=0.004. The overall safety profiles were comparable between the two treatment groups
Given the successful results from this pivotal Phase 3 trial and the previously reported Phase 2 opioid challenge study, Braeburn and Camurus look forward to working expeditiously with the FDA and EMA to begin the submission process to bring this potentially transformative new treatment to the many patients living with opioid use disorder in the US, Europe and other parts of the world. The FDA has granted Fast Track designation for CAM2038 subcutaneous injectable products for the treatment of opioid addiction.
For more information about CAM2038 and the Phase 3 trial, 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 and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 08.00 AM CET on 14 November 2016.
SOURCE Camurus AB