King Pharmaceuticals And Pain Therapeutics Announce Resubmission Of New Drug Application For REMOXY(R)
BRISTOL, Tenn. and SAN MATEO, Calif., Dec. 27, 2010 (GLOBE NEWSWIRE) -- King Pharmaceuticals ®, Inc. (NYSE:KG) and Pain Therapeutics ®, Inc. (Nasdaq:PTIE) today announced that King has resubmitted a New Drug Application (NDA) for REMOXY ® (oxycodone) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.
REMOXY ® is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. REMOXY was developed by Pain Therapeutics, using DURECT Corporation's (Nasdaq:DRRX) ORADUR ® technology, to help address the growing problem of non-medical use of prescription opioids. 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.
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 arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly neuroscience and hospital. King's wholly owned subsidiary, Alpharma, LLC, is also a leader in the development, registration, manufacture, and marketing of pharmaceutical products for food-producing animals. On October 11, 2010, King entered into an agreement and plan of merger with Pfizer Inc. pursuant to which Pfizer agreed to commence a tender offer to purchase all of the outstanding shares of common stock of King for $14.25 per share net to the seller in cash. The tender offer is ongoing.
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