FDA Approval of First Buprenorphine Implant for Opioid Abuse Disorders Follows Earlier Advisory Committee Support Recommendation

In an earlier installment of the Daily Dose, we reported on the favorable outcome of clinical trials of Probuphine®, a new therapeutic option for treatment of opioid dependence. Last week, the US Food and Drug Administration (FDA) announced its approval of Probuphine, as part of a comprehensive treatment program. Probuphine is a surgically implanted form of buprenorphine, designed to provide a constant, low-dose administration of the medication for 6 months. It offers enhanced patient convenience and safety for patients in stable recovery vs having to remember to take a daily pill or film form of the drug. FDA Commissioner Robert Califf, MD, commented, “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.” Probuphine is marketed by San Francisco-based Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals, Princeton, New Jersey.

A key component of FDA’s opioid action plan is expanded availability of medication-assisted treatment (MAT) approaches that combine approved medications such as methadone, naltrexone or buprenorphine with counseling and other behavioral therapies. Probuphine represents an additional medication option as part of a MAT approach which, according to the Substance Abuse and Mental Health Services Administration, can cut the risk of death from opioid use disorder in half. It consists of 4, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for 6 months. Administering Probuphine requires specific training because it must be surgically inserted and removed. FDA is further requiring postmarketing studies to establish the safety of re-implantation for additional courses of treatment, if required.

Read a news release on the action from the FDA website here.



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