RemoxyTreatment for Pain
Resubmission of Remoxy NDA
King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy
BRISTOL, Tenn. and SAN MATEO, Calif., Dec. 27, 2010 /PRNewswire/ -- King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. 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 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.
About Pain Therapeutics Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the Company has three other drug candidates in clinical programs. These include a novel monoclonal antibody-based treatment against metastatic melanoma. The Company is also developing a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this press release, the words "intend", "expect," "believe" and similar expressions are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include statements concerning, among other items, the Companies' expectations regarding the FDA's review of the Remoxy NDA and the tamper-resistance capabilities of Remoxy and ORADUR Technology. King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of each of the Companies' Annual Reports on Form 10-K for the fiscal year ended December 31, 2009, and their Quarterly Reports on Form 10-Q for the quarter ended September 30, 2010, each of which is on file with the U.S. Securities and Exchange Commission.
SOURCE King Pharmaceuticals, Inc.
Posted: December 2010
- FDA Complete Response Letter Received for Remoxy - June 24, 2011
- Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008
- Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008