Camurus AB (STO:CAMX) and Braeburn Pharmaceuticals said today that the companies submitted a new drug application to the FDA for its weekly and monthly buprenorphine depots to treat opioid use disorder.
Braeburn also reported that it applied for priority review of its application, which could potentially shorten the company’s path to the market.
The NDA submission was supported by positive data from a series of clinical trials, including a 47-patient Phase II trial which found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder.
The study met the primary endpoint for both dosages, blocking the effects of hydromorphone and suppressing withdrawal. The concentration of buprenorphine in patients’ plasma peaked at 24 hours, with CAM2038 sporting an apparent half-life of 4 to 5 days.
“Opioid addiction is an overwhelming public health epidemic in the U.S. Current daily medications for this condition are effective when taken as prescribed; however, for many patients, this can be a real challenge. Patients who do not take their medication as prescribed are ten times more likely to relapse,” Braeburn president & CEO Mike Derkacz said in prepared remarks. “If approved, patients will have access to a weekly and monthly dosing option that allows for flexible and individualized treatment from initiation on day one and throughout their recovery. This reduces the burden of daily medication, as well as the risks of misuse and diversion.”
“Since the completion of our comprehensive clinical program for CAM2038, we have worked relentlessly to finalize our regulatory submissions to make these potentially treatment-transforming investigational medicines available to patients with Opioid Use Disorder,” Camurus president & CEO Fredrik Tiberg added. “We are deeply appreciative of the important contributions of our investigators, nurses, and study participants, as well as the tireless efforts of our teams at Braeburn and Camurus, making this important milestone a truly collective achievement.”