In rare move, Purdue pulls out of abuse-deterrent OxyContin meeting with FDA
- Purdue was supposed to appear before the FDA's advisory panel of analgesic experts on July 7 to review data from its supplemental application for abuse-deterrent OxyContin.
- But now, the company is pulling out of the panel, saying that it wants more time to review its data before moving forward with its application.
- Purdue pulled its original version of OxyContin off the market in 2010 and replaced it with an abuse-deterrent formulation.
Purdue's recent move—canceling a meeting with the FDA and withdrawing an application—is a rare and bold course of action. After Purdue pulled its original formulation of OxyContin off the market and got a sign-off from the FDA three years later for label updates highlighting the difficulty of melting and injecting its new formulation, the goal was to run postmarketing studies. But, it seems, Purdue is not quite ready to share those results. And it could actually bode well for the company in the long-run.
Ideally, Purdue's results will show that their abuse-deterrent OxyContin has successfully decreased the rate of abuse. But only time will tell. Meanwhile, other companies have gotten involved in the abuse-deterrent pain market, including Pfizer and Teva, which are in late-stage development with their products.