Navigation Links
King Provides Additional Information on the REMOXY(R) NDA Resubmission Plan
Date:7/7/2009

BRISTOL, Tenn., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) today announced additional information regarding the resubmission plan for the REMOXY(R) New Drug Application (NDA). The Company is not required by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in order to provide additional safety or efficacy data in patients with moderate-to-severe chronic pain. However, as part of the resubmission plan, and in order to strengthen the NDA, King plans to conduct a likeability study and a pharmacokinetic trial in volunteers. The Company continues to anticipate the resubmission could occur mid-year 2010.

About REMOXY(R)

REMOXY(R), 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(R) was accepted by the FDA and was granted Priority Review. In December 2008, Pain Therapeutics, Inc. 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.

Forward Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). King Pharmaceuticals, Inc. disclaims 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 any information or conduct any study or trial in connection with the resubmission and the timing of any such study or trial. 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); the outcomes of any study or trial conducted in connection with the resubmission; and whether or when the NDA 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 King's Annual Report on Form 10-K for the year ended December 31, 2008 and it's Quarterly Report 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 medicine news :

1. Study provides hope that some transplant patients could live free of antirejection drugs
2. Study provides hope that some transplant patients could live free of anti-rejection drugs
3. USAID Provides Additional Wildfire Assistance to Greece
4. LifeMasters Provides Tips for Maintaining a Healthy Blood Cholesterol Level
5. New knock-out gene model provides molecular clues to breast cancer
6. PreMD Provides Update on 510(k) Application for PREVU(x) POC
7. SIV infection of natural hosts provides new insights into HIV disease complexity
8. Microarray provides 3 genomic guides to breast cancer treatment decisions
9. Access Innovations Provides Support Services for Agis Network
10. Crdentias VP of Marketing, Christina Hogan, Provides Exclusive Interview on Marketing Strategy
11. Physical Therapist Provides Injury Analysis for Fantasy Football
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology: