Navigation Links
King and Pain Therapeutics Announce REMOXY(R) NDA Update

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 arrangements and acquisitions, of novel branded prescription pharmaceutical products that complement the Company's focus in specialty-driven markets, particularly neuroscience, hospital care. King's wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, the Company has three drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia. For more information, please visit

Forward Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics, Inc. and King Pharmaceuticals, 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. Examples of such statements include, but are not limited to, any statements relating to the resubmission of the NDA for REMOXY(R), and the timing and content of any such resubmission; the need to generate stability data or any other information in connection with the resubmission; the Companies' plans to develop and commercialize REMOXY(R); the Companies' plans to work with the FDA in connection with the Complete Response Letter; and the potential approval of the NDA for REMOXY(R). Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in preparation and resubmission of the NDA for REMOXY(R) and whether or when the NDA for REMOXY(R) is approved by the FDA. Other 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 year ended December 31, 2008 and their respective Quarterly Reports on Form 10-Q for the quarter ended March 31, 2009, each of which is on file with the U.S. Securities and Exchange Commission.

SOURCE King Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cell Therapeutics Added to Russell 3000(R), Russell 2000(R) and Russell Global(R) Indexes
2. Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma
3. Horizon Therapeutics Names Dr. Jeffrey W. Sherman Executive Vice President and Chief Medical Officer
4. PTC Therapeutics Receives $2.6 Million in Government Grants
5. Cell Therapeutics on Preliminary List of Additions to Russell 3000(R) Index and Russell Global(R) Index
6. Nektar Therapeutics Promotes Lorianne Masuoka, M.D. to Chief Medical Officer
7. CSL Limited and Talecris Biotherapeutics Agree to Terminate Merger Agreement
8. Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions
9. Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions
10. Tobira Therapeutics Inc. Announces Key Addition to Scientific Advisory Board
11. PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice
Post Your Comments:
(Date:10/11/2017)... ... October 11, 2017 , ... Proscia Inc ... hosting a Webinar titled, “Pathology is going digital. Is your lab ready?” with ... adoption best practices and how Proscia improves lab economics and realizes an increase ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... implantation and pregnancy rates in frozen and fresh in vitro fertilization (IVF) ... and maternal age to IVF success. , After comparing the results from the ...
(Date:10/10/2017)... ... 2017 , ... For the second time in three years, ... Award. Representatives of the FirstHand program travelled to Washington, D.C. Tuesday, October 10th, ... mission is to change the trajectory of STEM education in America by dramatically ...
(Date:10/10/2017)... ... October 10, 2017 , ... USDM Life ... for the life sciences and healthcare industries, announces a presentation by Subbu Viswanathan ... The presentation, “Automating GxP Validation for Agile Cloud Platforms,” will present a revolutionary ...
Breaking Biology Technology:
(Date:4/18/2017)... 2017  Socionext Inc., a global expert in SoC-based imaging and ... the M820, which features the company,s hybrid codec technology. A demonstration ... Probe, Inc., will be showcased during the upcoming Medtec Japan at ... the Las Vegas Convention Center April 24-27. ... Click here for an ...
(Date:4/11/2017)... PALM BEACH GARDENS, Fla. , April 11, ... biometric identity management and secure authentication solutions, today ... million contract by Intelligence Advanced Research Projects Activity ... technologies for IARPA,s Thor program. "Innovation ... the onset and IARPA,s Thor program will allow ...
(Date:4/6/2017)... , April 6, 2017 ... RFID, ANPR, Document Readers, by End-Use (Transportation & Logistics, ... Facility, Oil, Gas & Fossil Generation Facility, Nuclear Power), ... Educational, Other) Are you looking for a ... sector? ...
Breaking Biology News(10 mins):