Phase III study of Probuphine (buprenorphine implant) meets endpoints in opioid dependence- Braeburn Pharmaceuticals

Braeburn Pharmaceuticals announces data from the Phase III study of Probuphine, a six month subdermal buprenorphine implant for the long-term maintenance treatment of opioid addiction. The study demonstrated that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine. The results show that participants in the implant group sustained clinical stability over the course of six months. The implant group was also more likely to remain free from illicit opioids at 85.7 % compared to 71.9 % of those maintained on sublingual buprenorphine.

The double-blind, double-dummy study was designed to determine the efficacy and safety of Probuphine as a maintenance treatment. The primary endpoint of non-inferiority was met�the responder rate was 87.6 percent in the sublingual buprenorphine group and 96.4 percent in the Probuphine group. The results showed statistically significant superiority for the implant versus the oral formulation. Side effects from treatment with buprenorphine included constipation, gastroenteritis, nasopharyngitis, headache and depression. Implant site related side effects included pain, pruritus, bruising and erythema.

The FDA is expected to make a decision on the approval of Probuphine by May 27, 2016. Data were presented at the 47th Annual American Society of Addiction Medicine (ASAM) Conference.