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FDA tentatively approves certain forms of Brixadi for opioid use disorder
The FDA tentatively approved certain Brixadi injections for treatment of moderate to severe opioid use disorder, according to a press release from Braeburn, the drug manufacturer.
Brixadi (buprenorphine, Braeburn) extended-release injections — 8 mg, 16 mg, 24 mg, 32 mg weekly and 64 mg, 96 mg, 128 mg monthly —are for patients who have already received buprenorphine or have already begun treatment with a single dose of a transmucosal buprenorphine product, the company stated.
According to the release from Braeburn, “FDA has concluded that Brixadi has met all required quality, safety and efficacy standards necessary for approval, but is not eligible for marketing in the U.S. because of exclusivity considerations.”
According to the company, this version of buprenorphine uses FluidCrystal Injection Depot Technology, a low-volume lipid-based liquid with a dissolved active ingredient. Once injected in the stomach, buttock, thigh or upper arm, the product “immediately starts transforming into a nanostructured liquid-crystalline gel, allowing for a slow release of the buprenorphine at a continuous and steady rate,” According to the release. The product does not need refrigeration, is administered only by health care providers in a health care setting and should be part of a complete treatment program that includes psychosocial support and counseling, the release stated.
“Brixadi supports current treatment guidelines that recommend frequent office visits, especially early in recovery, when patients may discontinue treatment and there is a high risk of overdose,” Mike Derkacz, president and CEO of Braeburn said in the release.
According to Braeburn, in a phase 3 trial among participants who either tested positive for fentanyl before the study or were using heroin and/or injectable opioids at study initiation, this version of buprenorphine met the noninferiority for responder rate (P < .001) when compared with daily sublingual buprenorphine/naloxone. The product also showed superiority to daily sublingual buprenorphine/naloxone in the percentage of negative opioid assessments from week 4 through 24 (P = .004).
The company reported that the safety profile of the weekly and monthly version of its buprenorphine generally mirrored that of oral buprenorphine. The most common adverse events were constipation, headache, injection-site pain and pruritus, insomnia, nausea and urinary tract infections, and these occurred in 5% or more of patients.
“Braeburn, and our partner Camurus, are currently reviewing FDA’s tentative approval of Brixadi and remain committed to taking appropriate actions with the goal of
Disclosure: Derkacz works for Braeburn.