Braeburn Pharmaceuticals and Camurus (STO:CAMX) touted data today from a long-term Phase III study of its weekly and monthly buprenorphine depots in patients with moderate-to-severe opioid use disorder.
The safety and efficacy study enrolled 228 patients and 71% of participants completed the 48-week treatment. The safety profile of CAM2038 was comparable to previous, shorter studies, according to the companies. No opioid overdoses were reported for patients treated with the buprenorphine depot injections.
“The positive results from this study, coupled with the earlier reported positive results from the pivotal Phase III efficacy trial, enable our teams to finalize regulatory submissions seeking approval in the U.S., Europe and other key global markets,” Braeburn president & CEO Behshad Sheldon said in prepared remarks. “Opioid addiction is an overwhelming public health epidemic. In the U.S. alone, there are 2.6 million patients diagnosed with opioid addiction, and approximately 30,000 people die every year from opioid overdoses. We look forward to bringing these innovative options of weekly and monthly buprenorphine medicines to patients as quickly as possible.”
“The successful completion of this study marks an important step forward in the development of provider administered, depot medications for the treatment of opioid use disorder,” principal investigator Dr. Michael Frost added. “Having both weekly and monthly formulations as well as multiple dosage strengths available, allows the treatment to be tailored to the individual needs of patients. Those who participated in the study tolerated the treatment well whether they were transitioned from other forms of buprenorphine or were new entrants to treatment.”
The researchers evaluated efficacy using weekly and monthly urine toxicology tests. On average, 75% of the urine samples were negative for illicit opioids over the 48-week trial period.
“These new Phase III results add to the growing body of evidence supporting the use of our weekly and monthly buprenorphine depots (CAM2038) as a flexible, individualized therapy for patients with opioid use disorder,” Camurus president & CEO Fredrik Tiberg said. “The present long-term study confirms the safety profile and efficacy of CAM2038 in both new-to-treatment patients and patients on maintenance treatment with daily buprenorphine. The results further strengthen our upcoming regulatory submissions to EMA and FDA in mid-2017.”