The FDA approved the first once-monthly injectable buprenorphine product (Sublocade, Indivior), for the treatment of moderate to severe opioid use disorder (OUD) in adult patients who have started treatment with a transmucosal buprenorphine-containing product. It is indicated for patients who have been on a stable dose of buprenorphine treatment for a minimum of seven days.
Buprenorphine for the treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth, or as an implant. An independent FDA advisory committee supported the approval of Sublocade in November.
Improving access to prevention, treatment and recovery services, including the full range of medication-assisted treatments, is a focus of the FDA’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.
Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is a drug–device combination product that uses buprenorphine and the Atrigel delivery system (Atrix Laboratories) in a prefilled syringe. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing period.
The safety and efficacy of Sublocade were evaluated in a randomized controlled trial and an open-label clinical trial involving 848 adults. Results indicated that Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of these patients had no evidence of illicit opioid use throughout the treatment period, compared with a placebo group.
The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer between-dose interval than monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose).
Sublocade has a boxed warning that provides important safety information, including the risks of intravenous self-administration. Sublocade will be provided to health care professionals through a restricted program, administered only by professionals in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form attesting they have procedures in place to ensure that Sublocade is dispensed only to health care professionals and not directly to patients.
The FDA granted this application priority review and fast track designations.