CUPERTINO, Calif., July 7 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) today reported that King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) have announced that King met with the Food and Drug Administration (FDA) on July 2, 2009 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). According to King Pharmaceuticals and Pain Therapeutics, the outcome of the meeting last week provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter.
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According to the King Pharmaceuticals / Pain Therapeutics press release, King now anticipates the resubmission of the NDA could occur mid-year 2010. King believes that the rate limiting step is the generation of six-month stability data, and no new clinical trials are required. King has stated that it remains committed to the development and commercialization of REMOXY and looks forward to working closely with the FDA toward approval of the product.
REMOXY, based on DURECT's ORADUR(TM) technology, is an investigational drug that is a unique, controlled release formulation of oxycodone 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.
About ORADUR(TM) Technology
ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of being less prone to abuse (e.g. by crushing or alcohol or water extraction) than other controlled release dosage forms on the market today.
Corporate Relationships
In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology which incorporate four specified opioid compounds. Under the license agreement, DURECT is reimbursed for formulation and other work performed under its agreement, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates.
