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Medical Devices / Submissions and Approvals

FDA Approves Monthly Buprenorphine MAT for Opioid Use Disorder

Dec. 5, 2017

The FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder.

Buprenorphine, a partial opioid agonist, is one of three drugs approved as an opioid MAT. First approved in 1981, it is currently available as a generic tablet, dissolvable film or implant.

Patients seeking treatment should be offered all three options, including naltrexone and methadone, to allow patients to receive the best-suited therapy, said FDA Commissioner Scott Gottlieb, who described agency plans to encourage wider use of MATs, as well as a more efficient approval pathway.

Last month, two FDA advisory committees overwhelmingly recommended approval of the pre-filled syringe; it will be distributed only to healthcare professionals for injection, to reduce the chances of diversion.

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