Embeda FDA Approval?

Embeda could be abused even though the company designed the drug not to be. Embeda contains morphine sulfate and Duramorph. Has Embeda gotten FDA approval?

asked by Marcus in Drugs & Medicine | 3280 views | 08-13-2009 at 09:46 PM

Yes. The Food and Drug Administration cleared the extended- release morphine product, Embeda. Embeda contains a chemical designed to counteract the morphine if the capsule is crushed, chewed or dissolved in alcohol to get the full dose at once. The company said, and the FDA agreed, the evidence wasn’t conclusive that the chemical truly interfered with the morphine high.

King Pharmaceuticals®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. EMBEDA is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

“Today’s approval of EMBEDA marks a milestone in pain care, and King is proud to bring this new technology to the U.S. market,” said Brian A. Markison, Chairman, President, and Chief Executive Officer of King. “King is committed to providing resources and medicines to patients and healthcare professionals to achieve optimal pain control. We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient. We anticipate a September 2009 launch for EMBEDA.”

answered by Dennis | 08-13-2009 at 09:48 PM

Don't buy stock in EMBEDA
I was on it for less than 8 hours and the side affects started and continually got worse for 2 days when I returned to my DR and was taken off the EMBEDA. I had a dry throat so bad that I couldn't talk. My head ached from my neck up and over my head into my right eye. I felt as though I was in withdrawal from my medication. I had previously been on Kadian 60MG. Kadian was working fine but for some reason my PM decided to try EMBEDA. I feel like I was a Guinea Pig. I look forward to being able to return to my Kadian tonight. I would not have been able to stand another night on EMBEDA.

Someone needs to listen close to the complaints about this drug. I have been reading negative posts all over the Net since I got home from the Doctor today. Shame on someone.

answered by Threewheellady | 04-15-2010 at 09:53 PM

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