FDA advisors recommend 2 opioid use disorder drugs
Two opioid use disorder drugs have been recommended for approval by FDA committees.
Two opioid use disorder (OUD) drugs have been recommended for approval by FDA committees.
In October, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and the Risk Management Advisory Committee voted 18 to 1 to recommend approval of Indivior's RBP-6000, an investigational once-monthly injectable buprenorphine formulation in the ATRIGEL delivery system for the treatment of adults with moderate-to-severe OUD, as part of a complete treatment plan to include counseling and psychosocial support.
Related: FDA requires warning on opioids
Then, in early November, the 2 committees voted 17-3 to recommend approval of CAM2038 (Braeburn Pharmaceuticals), an investigational buprenorphine weekly and monthly depot injection for the treatment of OUD.
"The panel's recommendation in favor of CAM2038 brings us another step closer to providing an individualized treatment option to support OUD patients from day one of their recovery, through initiation, to longer-term maintenance therapy," said Mike Derkacz, [resident and CEO of Braeburn. "The magnitude of the opioid crisis noted in the President's Commission report today reinforces the need for new, medication assisted therapies such as CAM2038, which is administered by healthcare professionals ensuring medication adherence, while potentially minimizing risks of diversion, abuse, misuse, and accidental pediatric exposure."
Related: Opioid patients lack access to treatment
In 2016, around 11.6 million adults misused opioids in the United States, but only 1.1 million received medication assisted therapy (MAT), according to the Substance Abuse and Mental Health Services Administration (SAMHSA).
The Advisory Committee's 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 a long-term safety study.
CAM2038 was accepted under Priority Review designation by FDA in September, 2017, and was previously granted fast-track designation.
Read more: How FDA aims to support generic opioids
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More
