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Roger Selvage 11023

New buprenorphine treatment option

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New Drug

Lauren Howell, PharmD

In May of 2023, FDA approved Brixadi (Braeburn Inc.), a new dosage form of the partial opioid agonist buprenorphine. This extended-release injection for subcutaneous use is indicated for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. This approval expands treatment options for patients looking to sustain long-term recovery from OUD.

Recommended dosage and administration

Brixadi should only be prepared and administered by health care providers. Doses should be administered slowly into the subcutaneous tissue of the buttock, thigh, abdomen, or upper arm. Providers should consider prescribing naloxone when Brixadi is initiated or renewed, since patients being treated for OUD have the potential for relapse, putting them at risk for opioid overdose.

Brixadi is available in both a weekly and monthly formulation. In patients who are not already receiving buprenorphine treatment, the recommended weekly dose is 24 mg titrated up over the first week of treatment.

A test dose of transmucosal buprenorphine 4 mg should be administered when objective signs of mild to moderate withdrawal appear. If the dose of transmucosal buprenorphine is tolerated without precipitated withdrawal, the first 16 mg dose of Brixadi (weekly) can be administered. An additional 8 mg dose of Brixadi (weekly) should be administered within 3 days of the first dose to achieve the recommended 24 mg Brixadi (weekly) dose.

If needed, an additional 8 mg dose can be administered during this first week as long as it is at least 24 hours after the previous injection. Subsequent Brixadi (weekly) injections can be administered based on the total weekly dose that was established during the first week of treatment. Adjustments can be made at weekly appointments with the maximum weekly dose being 32 mg. Patients who are already being treated with a buprenorphine-containing product may be switched directly to either the weekly or monthly Brixadi formulation.

Patients may also be transitioned from weekly to monthly or from monthly to weekly dosing based on clinical judgment. However, since Brixadi (weekly) and Brixadi (monthly) are different formulations, doses of the weekly formulation cannot be combined to yield an equivalent monthly dose.

For details on the recommended Brixadi weekly or monthly doses based on the corresponding daily doses of sublingual buprenorphine, please see the chart below.

Adverse effects

The most common adverse reactions associated with Brixadi administration were injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and UTI. Patients should be monitored for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Life-threatening respiratory depression and death have occurred in association with buprenorphine. Patients should be warned of the potential danger of self-administration of benzodiazepines and other central nervous system depressants while under treatment with Brixadi.

Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids, and wean the patient off the opioid. If treatment with Brixadi is discontinued, monitor patients for withdrawal and treat appropriately. Monitor liver function tests prior to and during treatment. The packaging of this product contains natural rubber latex which may cause allergic reactions. Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

Clinical trials

The safety and efficacy of Brixadi were evaluated in a randomized, double-blind, active-controlled clinical trial. A total of 428 patients with a diagnosis of moderate to severe OUD received an initial test dose of transmucosal buprenorphine and were then randomized to treatment with Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections. Patients were treated with weekly injections over 12 weeks and then transitioned to monthly injections for an additional 12 weeks. Urine drug screening and self-reporting of illicit opioid use during treatment were used to measure response to treatment. If patients completed each of the two phases with negative opioid assessments, they were considered a responder. In the Brixadi group, 16.9% of patients met the responder definition compared to 14.0% in the sublingual buprenorphine group. ■

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