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.