FDA Approves Monthly Buprenorphine Injection for Opioid Use Disorder
December 2017 ~
The U.S. Food and Drug Administration (FDA) has approved the first once-monthly injectable buprenorphine product: Sublocade, Indivior PLC for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients who have begun treatment with a transmucosal buprenorphine-containing product and whose dose of that drug was adjusted after initiation of treatment and who have been receiving that adjusted dose for a minimum of seven days.
The approval is based on data gathered from two clinical studies which use of the product in 848 adults diagnosed with moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film. Once on a stable dose, participants were given Sublocade by injection, with the response measured by urine drug screening and self-reporting of illicit opioid use over the six month treatment period. Patients treated with Sublocade were found to have had more weeks without positive urine tests or self-reports of opioid use than those in the control group. A higher portion of patients also had no evidence of illicit opioid use throughout the treatment period compared to the placebo group.
The Schedule III controlled substance must be prescribed or dispensed as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. The product will be issued to health care providers through a restricted program, administered only by providers in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form stating that they have procedures in place to ensure that the product is dispensed only to providers and not directly to patients.
According to the FDA’s press release, the approval of the drug is part of the group’s effort to improve access to prevention, treatment and recovery services, including the full range of medication-assisted treatments (MAT) – a major focus of the group’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis.