FDA blisters Purdue for 'poor' OxyContin data

Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster OxyContin [1] to an expert FDA panel, and promptly had their heads handed back to them.

"I'm fascinated with the poor scientific rigor" of the data, said panel member Jeffrey R. Kirsch, according to the Wall Street Journal. "It's almost insulting."

Purdue says this new version of the drug turns to a jelly-like substance when dissolved, making it almost impossible to inject with a syringe, a common practice among abusers. The panel will consider whether this new version can be marketed before long-term studies are completed.

- read the Wall Street Journal story [2]

Related Articles:
Purdue jumps ahead in pain drug race [1]
Conn. sues FDA for OxyContin warnings [3]
Kentucky sues Purdue over drug abuse [4]
Purdue execs plead guilty to OxyContin fraud [5]
Purdue cuts workforce as generic OxyContin gets green light [6]