FDA Alert

FDA Approves New Treatment Option for People With Opioid Use Disorder

Jessica Ganga

The FDA has approved a new buprenorphine treatment option for people with moderate-to-severe opioid use disorder. The new buprenorphine option is an extended-release injection for subcutaneous use and is available in two formulations: a weekly injection and a monthly version.

The approved weekly formulation of buprenorphine offers a new option for people who are in recovery that may benefit from a weekly injection to maintain treatment adherence. The weekly doses are available in 8 mg, 16 mg, 24 mg, and 32 mg doses. The monthly doses—for patients already being treated with buprenorphine—are available in 64 mg, 96 mg, and 128 mg doses.

The approval of buprenorphine follows a behavioral pharmacology study and a randomized, double-blind, active-controlled clinical trial (n = 428). Both studies were used to determine the safety and efficacy of treatment. The most common adverse reactions reported were injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at injection site, insomnia and urinary tract infections.

“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” FDA Commissioner Robert M. Califf, MD, said in a press release.

Additionally, the FDA noted the importance of counseling and other services in addition to the use of buprenorphine as part of a “comprehensive treatment plan for [opioid use disorder].” Although the prescribing of buprenorphine is not contingent on the implementation of counseling services, the FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) noted in a joint letter that “providing interventions in a person-centered manner is an important treatment principle.



FDA approves new buprenorphine treatment option for opioid use disorder. News release. US Food and Drug Administration; May 23, 2023. Accessed August 1, 2023.