Opioid Reformulation For Abuse Deterrence — Filed As A CMC Supplement In Less Than A Year

The client needed to reformulate a multiparticulate controlled-release opioid capsule for abuse deterrence. However, the company could afford neither the time nor the expense to perform further clinical studies beyond bioequivalence. Finding a way to limit and position the formulation change as only a chemistry, manufacturing, and controls (CMC) prior approval supplement (PAS) under the FDA’s scale-up and post approval changes (SUPAC) guidance would help. By simplifying and isolating the changes using a risk-based scientific approach designed to avoid clinical impact, additional clinical studies might be avoided, and the FDA should be more inclined to accept the change as a CMC supplement.

Read this case study to see how we leveraged innovative processing equipment from Freund-Vector to develop an efficient — and effective — solution.