Clinical Trials News
Braeburn says phase 3 trial for injectable opioid dependence treatment succeeds
PBR Staff Writer
Published 15 November 2016
A phase 3 trial of weekly and monthly injections of buprenorphine (CAM2038) to treat moderate-to-severe opioid use disorder met both FDA and EMA primary endpoints of non-inferiority.
Braeburn Pharmaceuticals and Camurus announced the positive top-line results from the pivotal phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine.
Apart from achieving the primary endpoint of non-inferiority, compared to daily sublingual buprenorphine/naloxone (current Standard of Care), CAM2038 also showed superiority for the key secondary endpoint.
In the phase 3 study, which enrolled 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.
Camurus president and CEO Fredrik Tiberg said: “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 confirmation of the strength and applicability of our proprietary FluidCrystal technologies and pipeline.
“The results of this rigorous evaluation of CAM2038 compared to standard of care provide strong support for our upcoming market authorization applications.”
The companies plan to work with the FDA and EMA to start the submission process . The FDA has granted fast track designation for CAM2038 subcutaneous injectable products to treat opioid addiction.
It is also subject to a 48-week safety trial of weekly and monthly CAM2038 that is being undertaken across 29 sites in the US, Australia and Europe.
A phase 2 trial is exploring whether weekly and monthly CAM2038 can be expected to produce same buprenorphine blood levels after administration at several injection sites.
More than 900 subjects have so far been enrolled in clinical studies assessing CAM2038.