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news.King Pharmaceuticals and Pain Therapeutics have announced the resubmission of Remoxy (oxycodone) new drug application (NDA) to the US Food and Drug Administration (FDA) in response to a complete response letter (CRL) received by Pain Therapeutics in December 2008.
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Earlier, Pain Therapeutics and King have entered into a strategic alliance to develop and commercialize Remoxy and other abuse-resistant opioid painkillers, in 2005.
Remoxy, developed by Pain Therapeutics, using Durect’s Oradur technology, is a formulation of oral oxycodone, which is a twice daily medicine for severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time.
Durect claims that its Oradur sustained released oral gel-cap technology provides the unique characteristics of Remoxy and the referenced follow-on products.