FDA Approves Reformulated Oxycontin

The FDA has approved Purdue Pharma’s NDA for a reformulation of OxyContin (oxycodone HCl controlled-release) Tablets. The reformulated tablet meets the FDA’s criteria for bioequivalence to the original formulation and is an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse.

OxyContin is a CII controlled substance with all the risks of Schedule II opioids, in particular, that the drug has a high potential for abuse. The reformulated tablets are designed to be harder to crush and more difficult to dissolve, as opposed to current tablets that can be easily crushed or chewed, allowing all of the drug’s active ingredient to immediately be released.