The FDA has once again rejected Pfizer and Pain Therapeutics' application for Remoxy, an extended-release version of oxycodone that has been altered to taste bad and be harder to chew--properties the companies had hoped would make the drug less prone to abuse.
In a release, Pfizer didn't say what prompted the FDA's complete response letter, only that the companies were evaluating issues raised by the FDA. "Pfizer is working to understand and address the issues in the FDA Complete Response Letter," said Olivier Brandicourt, Pfizer president and general manager, Primary Care. "Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue."
Pifzer inherited the drug in its $3.6 billion acquisition of King Pharmaceuticals, which in 2005 inked a deal with Pain Therapeutics. This marks Remoxy's second FDA rejection; regulators also shot it down in 2008 and asked for more data on the drug.
- here's the Pfizer release
- read The Street report for more