Remoxy (oxycodone), designed to provide 24-hour pain relief for moderate to severe pain, has been re-submitted to the FDA (Food and Drug Administration) by King Pharmaceuticals Inc. and Pain Therapeutics Inc. Remoxy is also designed for long-term use. The re-submission follows an FDA Complete Response Letter (CRL) sent in 2008. According to King Pharmaceuticals, “This is a Class 2 resubmission with a six month review cycle.”
The FDA had held back on approval saying that it needed more proof that Remoxy cuts down on abuse.
King Pharmaceuticals is in the process of being taken over by Pfizer Inc. in a $3.6 billion deal.
Industry experts had expected a much earlier re-submission of Remoxy. When the two companies announced last year that they were postponing the filing, Pain Therapeutics shares dropped considerably. According to the Wall Street Journal, King’s shares have risen by 15% and Pain’s by 21% so far this year.
In a communiqué today, King Pharmaceuticals wrote:
- “Remoxy is comprised of a high-viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.
Remoxy is designed to treat pain by slowly releasing the narcotic oxycodone.
Source: King Pharmaceuticals, various financial media
Written by Christian Nordqvist