FDA approves extended-release buprenorphine injection for opioid use disorder

Key takeaways:

• Brixadi is the first long-acting buprenorphine injectable that is available in weekly and monthly doses.
• Patients receiving a transmucosal buprenorphine product can switch to an equivalent dose of Brixadi.

The FDA announced that it has approved Brixadi, an extended-release subcutaneous injection for the treatment of moderate to severe opioid use disorder.

Brixadi (buprenorphine, Braeburn Inc.) is the first long-acting buprenorphine injectable that can be given in weekly or monthly doses to patients with opioid use disorder (OUD) who have already initiated treatment with transmucosal buprenorphine or who are already receiving buprenorphine treatment, according to the manufacturer.

“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.

Buprenorphine is a safe and effective treatment option for patients with OUD, the FDA said in the release. According to the Substance Abuse and Mental Health Services Administration, it can halve patients’ risk for death from all causes.

The approval of Brixadi is partly based on data from a randomized, double-blind, active-controlled clinical trial, in which 428 adults with moderate to severe OUD were randomly assigned to Brixadi plus sublingual placebo or an active sublingual buprenorphine product plus placebo injections. After a week of titration, patients received weekly injections for 12 weeks and then switched to monthly injections for an additional 12 weeks. The proportion of patients with negative opioid assessments at the end of each treatment phase was 16.9% in the Brixadi group vs. 14% in the sublingual buprenorphine group, according to the FDA.

The approved doses of Brixadi vary. Weekly doses include 8 mg, 16 mg, 24 mg and 32 mg, and the monthly doses include 64 mg, 96 mg and 128 mg. The various lower strengths of the weekly formulation represent a new option for patients who are in recovery and “may benefit from a weekly injection to maintain treatment adherence,” the FDA said. The most common adverse events associated with Brixadi are injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and UTI, according to the FDA. The treatment will be available through a Risk Evaluation and Mitigation Strategy program and can only be administered by health care providers.

References:

• Braeburn's BRIXADI (buprenorphine) extended-release subcutaneous injection (CIII) receives FDA approval for moderate to severe opioid use disorder. https://braeburnrx.com/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder. Published May 23, 2023. Accessed May 23, 2023.
• FDA approves new buprenorphine treatment option for opioid use disorder. https://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder. Published May 23, 2023. Accessed May 23, 2023.