FDA blisters Purdue for 'poor' OxyContin data

Tue, 06 May 2008 06:59:56 -0400

Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster OxyContin 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

Purdue jumps ahead in pain drug race

Tue, 29 Apr 2008 06:59:56 -0400

With three significant development programs at work on a tamper-free alternative to the blockbuster OxyContin franchise, Purdue Pharma is bracing for an upcoming FDA panel review of its new pain therapy formulation. Pain Therapeutics, Alpharma and Elite Pharmaceuticals all hope to gain approvals for their own therapies, notes Pharmalot. But Purdue plans to beat them to it.

No one knows exactly what makes the new Purdue therapy tamper-proof, but there have been hints about a certain "rubbery" quality to the new drug. Just a year ago executives with Purdue pleaded guilty to charges that they had misled regulators on the addictive risks presented by OxyContin, which brought in a billion dollars in sales last year.

- check out the report in Pharmalot