For the study, probuphine implants were compared with buprenorphine film on “stable” patients, those who had already been taking 8 mg or less of the dissolvable buprenorphine film per day. After 6 months, 85% of those on probuphine tested negative for illegal drugs, compared with 72% of those taking the buprenorphine film.
Rupp noted that the study had multiple flaws: some missing urine samples were counted as negative. However, people addicted to opioids “often skip tests to avoid a positive test,” which could skew results.
The committee’s acting chairwoman Judith Kramer also voted against recommending probuphine’s approval because doctors don’t yet know if it’s effective for more than 6 months, and many people who are addicted to opioids need to take medications for years.
Rupp also had concerns that doctors don’t yet know how to safely transition patients from buprenorphine films to the implant, which might put patients at risk for a relapse during the transition. “This is an unacceptable risk for stable patients,” Rupp said.
The study also didn’t match the demographics of addicts across the United States: 84% of patients in the study were white.
“This is not the real world of opioid addiction,” Rupp said. “Many of these patients will require treatment for years. We need long-term safety data from diverse populations. Patients will require a new incision every 6 months, creating an ongoing risk of harm due to bleeding and infectious complications.”
1. Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval of Probuphine, First 6-Month Implant to Treat Opioid Addiction. PRNewswire. prn.to/1W8ezx7. Accessed January 13, 2016.
2. Panel recommends FDA approve implant to treat opiate addiction. USAToday. usat.ly/1Q3m48h. Accessed January 13, 2016.
This article originally appeared on Psychiatry Advisor