In 2016, roughly 11.6 million adults misused opioids in the US, yet only 1.1 million received medication-assisted therapy.
Braeburn Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted to recommend approval of CAM2030 for the treatment of adults with opioid use disorder (OUD).
The FDA asked the committee to vote on recommended approval of all, some, or none of the proposed doses of CAM2038. The committee jointly voted 17 in favor of approval of some of the proposed doses, and 3 in favor of none of the proposed doses.
“We are pleased that on Nov. 1, the FDA’s Advisory Committee panel voted to recommend CAM2038 which, if approved, will provide physicians with new, weekly and monthly injectable medication-assisted therapies (MAT) for their opioid use disorder patients, to help address the escalating burden of opioid addiction in this country,” Mike Derkacz, President and chief executive officer, Braeburn, told MD Magazine. “Because CAM2038 is administered solely by healthcare professionals, it may help mitigate the inherent risks of daily oral medication in terms of diversion, abuse, misuse and pediatric exposure.”
The recommendation was based on a review of results from a clinical trial program that included 7 phase 1-3 clinical trials in patients with OUD, including a pivotal phase 3 efficacy and long-term safety study.
The 12 month, long-term safety study utilized CAM2038 once weekly and once monthly and had 3 phases: screening, treatment and follow up. The primary outcome measure was the safety and tolerability of CAM2038 products in 100 adult outpatients with opioid use disorder via safety assessments like adverse effects and serious effects, clinical laboratory tests, electrocardiogram (ECG), vital signs, physical and injection site examinations and concomitant medications.
The second outcome measure included evaluating the efficacy of CAM2038 through several efficacy parameters including urine toxicology, signs and symptoms of withdrawal and cravings.
The injection depot for once weekly administration included 8, 16, 24 or 32 mg doses, while the injection depot for once monthly administration included doses of 64, 96, 128 or 160 mg doses.
The safety profile of CAM2038 was consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse effects.
CAM2038, an investigational buprenorphine once weekly and once monthly depot injection, is evaluated for the treatment of opioid use disorder and is part of a comprehensive treatment plan which includes counseling and psychosocial support.
The product is designed for flexible and individualized treatment from initiation and stabilization to long-term maintenance therapy. The administration by healthcare professionals ensures adherence while minimizing risks.
It’s presented ready for use in prefilled syringes for weekly or monthly administrated by a healthcare professional.
If approval, it will be offered in dosage strengths for once weekly, 8 mg—32 mg, and once monthly 64 mg–160 mg subcutaneous injections.
According to the Substance Abuse and Mental Health Services Administration, in 2016, about 11.6 million adults misused opioids in the US, while only 1.1 million received medication-assisted therapy.
Opioid overdose is now the leading cause of death among people under 50 in the US. The White House Commission report outlined the critical need for medication assisted therapy in treating opioid addiction, calling for increased funding for addiction related activities.
CAM2038 was accepted under priority review designation by the FDA in September and has set a target Prescription Drug User Fee Act (PDUFA) date of January 19, 2018.
A press release was made available.