Braeburn Pharmaceuticals announced positive data from the Phase 3 study of Probuphine (buprenorphine subdermal implant) for the long-term maintenance treatment of opioid addiction. Findings were presented at the 47th Annual American Society of Addiction Medicine (ASAM) Conference.

The Phase 3 study is a double-blind, double-dummy trial designed to evaluate the efficacy and safety of Probuphine as a maintenance treatment for opioid addiction. The primary endpoint was to show non-inferiority to sublingual buprenorphine.

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Study results demonstrated that patients who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine. In addition, patients in the Probuphine group were more likely to be abstinent from illicit opioid use for 6 months compared to patients who remained in the sublingual buprenorphine group. The responder rate for the Probuphine group was 96.4% vs. 87.6% in sublingual buprenorphine group, meeting the study’s primary endpoint (P=0.034).

The FDA is expected to make a decision on the approval of Probuphine by May 27, 2016.

Probuphine, an opioid antagonist, is a long-acting, 6-month, subdermal implant utilizing Titan’s platform technology ProNeura, which is designed to provide continuous, long- term steady state levels of medication in the blood. Currently, buprenorphine is only available as a once-daily oral formulation.

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