Medicine

FDA Approves Once-Monthly Injection for Opioid Addiction

FDA Approves Once-Monthly Injection for Opioid Addiction

Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.

"Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety".

The FDA Commissioner noted the importance of providing an array of treatment options for opioid use disorder. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. Sublocade is a drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is injected as a solution and the delivery system forms a buprenorphine-containing depot that releases the drug as the depot breaks down.

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Sublocade is a CIII controlled substance and should be administered by a clinician as part of a complete treatment program that includes counseling and psychosocial support. "Sublocade is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a one month period".

Indivior has received approval from the USA drug regulator to market its once-monthly injectable treatment for moderate to severe opioid use disorder, which analysts believe could lift company sales north of $1bn. Clinical studies showed that patients treated with Sublocade had fewer weeks with positive urine tests and self-reported opioid use vs patients receiving placebo. The most common side effects included constipation, nausea, vomiting, headache, drowsiness and injection-site pain. Sublocade's safety and effectiveness were not evaluated in individuals under age 17, the FDA said. Postmarketing studies will assess the necessity of the pretreatment stabilization regimen with sublingual buprenorphine, the benefits of higher doses of Sublocade in patient subpopulations, and the efficacy of longer interdose intervals. It carries a boxed warning that includes the risk of intravenous (IV) self-administration that can result in occlusion, tissue damage, or embolus.


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