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FDA Advisors Recommend Approval of Probuphine to Treat Opioid Addiction
The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has voted 12 to 5 in favor of approving probuphine (Titan Pharmaceuticals/Braeburn Pharmaceuticals), the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction in stable patients receiving 8 mg or less per day of buprenorphine. The committee’s vote followed a discussion of data regarding the treatment’s efficacy, safety, and risk–benefit profile.
The new drug application (NDA) for probuphine was resubmitted to the FDA in August 2015 and was accepted in September. A target agency action date has been set for February 27, 2016.
The FDA is not obligated to follow the recommendations of its advisory panels, but it usually does so.
Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months after a single treatment, and to promote patient compliance and retention. Buprenorphine –– the active ingredient in several FDA-approved drug products for the treatment of opioid dependence –– is currently available in tablet and film formulations that require self-administration by patients on a daily basis.
Probuphine was developed using a continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period.
The efficacy and safety of probuphine have been studied in several clinical trials, including a 24-week placebo-controlled study in 163 subjects (published in the Journal of the American Medical Association) and a follow-on study in 287 subjects (published in Addiction).
Source: Titan Pharmaceuticals; January 12, 2016.