Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
Braeburn gained FDA approval on May 23, 2023, for its Brixadi™ extended-release injection, a new formulation of the partial opioid agonist, buprenorphine. It is indicated as part of a comprehensive treatment, counseling and support program for patients who have moderate-to-severe opioid use disorder (OUD). Patients who have had one dose of a dissolving film form of buprenorphine and those already being treated with a daily buprenorphine film are candidates for transitioning to Brixadi. In a phase III clinical trial, the effectiveness of Brixadi was comparable to that of a sublingual (SL) buprenorphine/naloxone product, but more patients receiving Brixadi had negative tests for opioids from the four-week mark through the rest of the 24-week-long study.
Beginning in September 2023, it will be marketed in single-dose prefilled syringes at 8mg, 16mg, 24mg and 32mg for once-weekly administration, and at 64mg, 96mg and 128mg for once-monthly dosing. A large network of certified specialty pharmacies will be dispensing it. A healthcare professional will inject the appropriate dose into the patient’s abdomen, buttocks, thigh or upper arm. Lower strengths cannot be used together to make a higher dose, injections cannot be divided into more than one shot and doses must be given SC. Because Brixadi becomes a jelly when mixed with a liquid, it carries a boxed warning that injecting it any way other than SC could result in blood clots and tissue damage.
A C-III controlled substance, Brixadi has a risk evaluation and mitigation strategy (REMS) that limits its prescribing and delivery to providers who are trained and certified to prescribe and inject it. Pharmacies also must have special certifications to dispense it. Patients must be enrolled in the REMS, as well.
Impact to Workers’ Comp
Considering the potential for misuse of opioids, treatment of OUD is of interest in those claims where an opioid has been prescribed.
For any questions about the use of Brixadi, opioids, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.