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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by Katgirl on November 14, 2009, at 15:45:08
OK, I thought I added to a "string" to ask this question but I can't find it. This sleep med has apparently been delayed by the FDA because they want more information on the risk-benefit of the drug. Does that mean that the drug caused horrible health problems (aka "the risk") during the trial?? I keep hoping these newer drugs will be cleaner, but maybe its just too much to ask!
Posted by Phidippus on November 14, 2009, at 15:57:06
In reply to Epilvanserin--new sleep med, posted by Katgirl on November 14, 2009, at 15:45:08
Eplivanserin is an inverse agonist on the serotonin receptor subtype 5-HT2A. There were no mentions of health risks during the trials-it is currently in Phase II trials.
This looks to be a very clean drug.
P
Posted by Phillipa on November 14, 2009, at 18:58:01
In reply to Re: Epilvanserin--new sleep med » Katgirl, posted by Phidippus on November 14, 2009, at 15:57:06
Welcome to babble if your're new. Phillipa
Posted by Katgirl on November 15, 2009, at 9:16:05
In reply to Re: Epilvanserin--new sleep med » Phidippus, posted by Phillipa on November 14, 2009, at 18:58:01
Actually it has completed phase III and they thought the drug was going to launch in a few months, but the FDA wants more information in regards to "risk-benefit". They will be meeting with the FDA to see if that means they have to go back and do more trials or if they can take information from the trials they have already done. I just wondered what in the final phase III results could have raised the FDA's concern.
Posted by Katgirl on November 15, 2009, at 9:16:42
In reply to Re: Epilvanserin--new sleep med » Phidippus, posted by Phillipa on November 14, 2009, at 18:58:01
This is the end of the thread.
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