Titan and Braeburn announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the Food and Drug Administration (FDA) has recommended the approval of Probuphine. This is the first long-acting subdermal buprenorphine implant for the maintenance treatment of opioid addiction in stable patients receiving ≤8mg/day of buprenorphine.
The Committee voted 12-5 in favor of its approval following the presentation of clinical trial data on Probuphine’s efficacy, safety, and risk-benefit profile. Its New Drug Application (NDA) was resubmitted in August 2015 and accepted by the FDA in September 2015.
Probuphine is a subdermal implant that delivers continuous buprenorphine for 6 months following a single treatment, promoting patient compliance and retention. It utilizes ProNeura, a continuous drug delivery system that is made up of a small, solid implant (ethylene-vinyl acetate and a drug substance mixture). The solid matrix is placed typically in the upper arm during an outpatient office procedure, and then removed at the end of the treatment period.
Its safety and efficacy have been studied in earlier trials, including a 24-week, placebo-controlled study (n=163) and a follow-on study (n=287). Data from its most recent trial supported its efficacy as a 6-month maintenance treatment for opioid dependence in the study population. Multiple sensitivity analyses were also conducted to investigate the robustness of the results. The Companies also presented safety data focusing on the Probuphine insertion and removal procedures, as well as a proposed Risk Evaluation and Mitigation Strategy (REMS).
Buprenorphine is already available in tablet and film formulations for self-administration each day.
The Agency has set a target action date for February 27, 2016. The FDA is not obligated to follow the recommendations of its Advisory Committee but will take it into consideration as it completes the Probuphine NDA review.