Braeburn Pharmaceuticals presented data from the Phase 3 study of Probuphine for the long-term maintenance treatment of opioid dependence at the 78th Annual Scientific Meeting of The College on Problems of Drug Dependence (CPDD).
Probuphine, a subdermal buprenorphine implant, is the only six-month treatment for opioid dependence approved by the Food and Drug Administration (FDA) on May 26, 2016.
Data presented showed that patients who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine. The study also found that patients treated with Probuphine were more likely to sustain abstinence from illicit opioids throughout the 6 months compared to patients who remained on sublingual buprenorphine. Probuphine demonstrated superiority over sublingual buprenorphine, showing that 96.4% of Probuphine-treated patients avoided drug use for at least 4 months vs. 87.6% in the sublingual buprenorphine group (P=0.034). In addition, a statistically significant difference was found between Probuphine and sublingual buprenorphine in the proportion of patients for all 6 months without evidence of illicit opioid use (85.7% vs. 71.9%, P=0.03).
Probuphine is indicated as part of a complete treatment program, including counseling and psychosocial support, for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product.
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