BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response Letter.
King now anticipates the resubmission of the NDA could occur mid-year 2010. The Company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of REMOXY(R), and looks forward to working closely with the FDA toward approval of the product.
REMOXY, an investigational drug, is a unique, long-acting oxycodone formulation for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for REMOXY was accepted by the FDA and was granted Priority Review. In December 2008, Pain Therapeutics received a Complete Response Letter from the FDA. Subsequent to the receipt of the Complete Response Letter, King assumed full control of all activities related to the development of REMOXY(R).
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangement
|SOURCE King Pharmaceuticals, Inc.|
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