EmbedaTreatment for Pain
Update: Embeda Now FDA Approved - August 13, 2009
Update on Embeda NDA Review
King Pharmaceuticals Provides Update on Embeda NDA Review
BRISTOL, Tenn.--(BUSINESS WIRE)--Dec 31, 2008 - King Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules. It is likely that this review will extend into early 2009.
"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Eric Carter, Chief Science Officer of King Pharmaceuticals. "We look forward to working closely with the agency as needed throughout the review process."
Utilizing King's proprietary technology, Embeda Capsules contain extended-release morphine pellets, each with a sequestered core of naltrexone, an opioid antagonist. The formulation is designed to work such that if taken as directed, the morphine would relieve pain while the sequestered naltrexone would pass through the body with no observed clinical effect. If Embeda Capsules are crushed or chewed, the naltrexone would be released, mitigating the euphoric effect of the morphine.
About King Pharmaceuticals
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, hospital and acute care. King is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.
This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the potential benefits of Embeda if approved. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on the unpredictability of the duration and results of the FDA's review of the Embeda NDA. 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 Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ended September 30, 2008, which are on file with the U.S. Securities and Exchange Commission ("SEC"). King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
Contact: King Pharmaceuticals, Inc.
James E. Green, Executive Vice President, Corporate Affairs
David E. Robinson, Senior Director, Corporate Affairs
Posted: December 2008
- FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone) - October 17, 2014
- FDA Approves Embeda For Management of Moderate to Severe Chronic Pain - August 13, 2009
- Alpharma Announces Acceptance of the Embeda Capsule NDA Filing - September 2, 2008
- Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules - July 1, 2008
- Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda - April 22, 2008
- Alpharma Submits New Drug Application for Embeda - February 29, 2008