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 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

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

Suggested Articles

What a difference a day makes in biotech.

A report out this week by PwC thinks that biotech could be in for a good year for deals as it sees the momentum from 2019 growing.

A drug developed at Temple restores a mechanism in brain cells that prevents the toxic buildup of the proteins amyloid beta and tau in Alzheimer's.