Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder.
The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized intramuscular hydromorphone injections. After the 1st 3-day session, patients were randomized to weekly CAM2038 at 24mg or 32mg and the assigned dose was given at day 0 and day 7.
Researchers conducted 4 sets of hydromorphone sessions to evaluate the depot’s ability to block the effects of opioids.
“CAM2038 produced clinically relevant buprenorphine plasma levels, translating into rapid and sustained opioid blockade and withdrawal suppression, and was well tolerated both systemically and locally,” trial investigator Sharon Walsh said in prepared remarks. “As reported in JAMA Psychiatry, trial results suggest that CAM2038 formulations would be effective in reducing illicit opioid use and relapse, while eliminating the risk for misuse and diversion.”
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.
The product was safely tolerated and had adverse events consistent with other trials, including injection-site pain and constipation.