This was Probuphine’s second bid for approval; the first, brought forward in March 2013 by Titan Pharmaceuticals, was for approval for individuals who had been taking up to 16 mg of buprenorphine daily. However, pharmacokinetic data indicated that the four 26mm subdermally implanted rods, each containing 80 mg of buprenorphine in a depot formulation, would yield a steady-state plasma concentration equivalent to a 12 mg/day transmucosal dose, over a 6-month period.
A risk evaluation and mitigation strategy (REMS) for both prescribers and those inserting and removing Probuphine will be required.
The agency usually follows the recommendations of its advisory panels, but the recommendations are not binding.
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