Probuphine rejection by FDA: Adequate dosing a key concern

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By Alison Knopf

When the Food and Drug Administration (FDA) rejected the New Drug Application (NDA) for buprenorphine implant Probuphine on April 30, there was surprise on Wall Street and among many in the treatment community. An FDA advisory committee had recommended weeks before that Probuphine be approved (see ADAW, April 1).

Despite the fact that clinical trials showed that only 8 percent of patients were opioid-free throughout the treatment, perhaps signaling problems with determining an adequate dosage, the expectation was that since it was more effective than placebo, Probuphine would be approved. Overall, 35 percent of the Probuphine patients and 72 percent of the placebo patients in the controlled trials did not complete the six-month treatment course. The most common reason in the placebo patients was “treatment failure,” which was defined as needing additional sublingual buprenorphine beyond preset amounts. The trials did not define continued use of illicit substances as treatment failure.

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