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Breaking the Silence

From the 12/14 Show - FDA Makes Correct Decision - Remoxy Appears Dead

December 17, 2008 00:58 by larry

The show started with a 1993 sound bite from The Simpson’s.  Homer Simpson had to decide between “eating the last piece of donut or going to donut hell”.  Homer, unfortunately, ate the last piece of donut and had to face the devil.

It was my request on the show that the FDA does not eat the last piece of donut concerning the drug Remoxy.  The FDA delayed the release of Remoxy last week, but continued to leave the door open for a possible future release. 

How would Remoxy be marketed, if approved?   I can see the package insert for Remoxy: “Remoxy is better than OxyContin because the chance of addiction may be the same, but Remoxy may be able to reduce deaths from OxyContin by less than 3%.”   A legacy the FDA can’t accept.

I maintain that Remoxy is effectively dead and I openly asked the executives from Pain Therapeutics to call into the show and help us convince the FDA that new indications for all of the controlled release oxycodone products (OxyContin) be revised to being recommended for terminal pain and a limited amount of additional medical situations.

Comments are welcome.


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