The injection Brixadi from Braeburn has received FDA approval to treat moderate-to-severe opioid use disorder.

For the treatment of moderate-to-severe opioid use disorder (OUD), the FDA has authorised the extended-release subcutaneous injectable form of buprenorphine (Brixadi; Braeburn Inc).

For patients who have begun therapy with a single dosage of a transmucosal buprenorphine product or who are currently receiving buprenorphine, the medication is offered in two formulations: a weekly injection and a monthly version.

"Buprenorphine is a crucial component of [OUD] treatment." The FDA Commissioner Robert M. Califf, MD, noted in a news statement that today's clearance "expands dosing options and gives people with [OUD] a greater opportunity to sustain long-term recovery." As stated in the FDA's Overdose Prevention Framework, "The FDA will continue to take the critical actions required to pursue efforts that advance evidence-based treatments for substance use disorders."

There are other dosages of buprenorphine injection that have been approved, including a lower dose for people who are unable to take the larger doses of extended-release buprenorphine that are now offered. There are four different weekly strengths: 8 mg, 16 mg, 24 mg, and 32 mg. The three different monthly strengths are 128 mg, 96 mg, and 64 mg.

The weekly formulation, which comes in a variety of lower doses, will provide a new alternative for people in recovery who could benefit from receiving an injection once a week to help them stay on top of their treatment regimen.

A randomised, double-blind, active-controlled clinical trial involving 428 people with a diagnosis of moderate-to-served OUD and evaluation in behavioural pharmacology study that assessed the 2 weekly doses of the drug and its capacity to block the subjective effects of opioids led to the decision.

Participants in the research were randomly assigned to receive either the buprenorphine injection combined with a sublingual placebo or active sublingual buprenorphine combined with a placebo injection following the transmucosal buprenorphine first test.

Following the initial week of titration, the patients had weekly injections for 12 weeks before switching to monthly injections for an additional 12 weeks.

The FDA's Risk Evaluation and Mitigation Strategy programme will make the buprenorphine injection available, and medical professionals will administer it there.

In a letter released earlier this month, the FDA and the Substance Abuse and Mental Health Services Administration underlined the value of counselling and other services that have to be incorporated into an OUD treatment plan. They said that buprenorphine distribution shouldn't be contingent on users of these programmes.

Reference

New buprenorphine treatment option for opioid use disorder gets approved by the FDA. a press release. FDA in the United States. May 23, 2023. Retrieved on May 24, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder?utm_medium=email&utm_source=govdelivery