EmbedaTreatment for Pain
Update: Embeda Now FDA Approved - August 13, 2009
Embeda NDA Accepted
Alpharma Announces Acceptance of the Embeda Capsule NDA Filing
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Sep 2, 2008 - Alpharma Inc., a global specialty pharmaceutical company, today announced that the United States Food and Drug Administration ("FDA") has advised the Company that its New Drug Application ("NDA") for Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules has been accepted and designated for priority review. The priority review status provides for a review period of six months from the date of submission. The Embeda Capsule NDA was submitted on June 30, 2008.
"We are pleased with the FDA's decision to grant the Embeda Capsule application a priority review and now anticipate the potential for an advisory panel meeting, where we can share the positive results from our Phase III clinical trials in the appropriate public forum," commented Dean Mitchell, President and Chief Executive Officer. "We remain committed to further development of novel alternatives for the treatment of chronic pain utilizing Alpharma's proprietary abuse deterrent technology, and look forward to collaborating with the FDA on safe and effective solutions."
Embeda Capsules were developed using Alpharma's proprietary technology, which combines an extended-release opioid with sequestered naltrexone, an opioid antagonist. In clinical trials, when Embeda Capsules were taken as directed, pain relief was provided and the sequestered naltrexone passed through the body without observed clinical effect. If an Embeda Capsule is crushed or dissolved in alcohol, which are common approaches abusers use to tamper with an opioid product in order to gain euphoria, both the morphine and the naltrexone are released. When both are released, the study results showed that the euphoric effect of morphine was significantly reduced. The Embeda Capsule is an investigational pharmacological extended release opioid in development for the relief of moderate to severe chronic pain.
Statements made in this press release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Information on other important potential risks and uncertainties not discussed herein may be found in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2007.
Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 80 countries. Alpharma has a growing branded pharmaceutical franchise in the U.S. pain market with its KADIAN(R) (morphine sulfate extended-release) Capsules, and the FLECTOR(R) Patch (diclofenac epolamine topical patch) 1.3%. Alpharma is also internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.
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Jack Howarth, 908-566-4153
Vice President, Investor Relations
Kekst and Company
Kimberly Kriger/Thomas Davies, 212-521-4800 (Media)
Posted: September 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
- King Pharmaceuticals Provides Update on Embeda NDA Review - December 31, 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