Posted by MarkinBoston on October 23, 2000, at 17:37:00
In reply to Re: ghb (Xyrem) is still not FDA approved » ash, posted by Ant-Rock on October 19, 2000, at 18:06:40
Slick move. Too much negativity associated with the name GHB, so call it sodium oxybate instead and avoid all the red flags and stigma!
Same thing happens over and over. MRI scans used to be called NMR (Nuclear Magnetic Resonance) scans. No radioactivity was involved, but the name brought up images of the bomb and 3-Mile Island resulting in patient concern.
Now I give XYREM half a chance of Schedule II status approval unless some loser in the media wants to try and enhance their career at the expense of the suffering of many thousands of people by 'exposing' the rouse. It may not be GHB, though what little they say about it helping narcoleptics and improving sleep architecture is also true of GHB. I think Schedule II or III is appropriate considering interaction potential and need for careful use.
The company also has an injectable to treat anti-freeze poisoning, which is interesting. The traditional treatment has been ethanol.
> Xyrem(R)Sodium Oxybate) Oral Solution NDA Receives Priority Review from the FDA
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> MINNEAPOLIS, Oct. 17 /PRNewswire/ -- Orphan Medical, Inc. (Nasdaq: ORPH) announced today that the Food and Drug Administration (FDA) has granted the Company's Xyrem(R) (sodium oxybate) oral solution New Drug Application (NDA) priority review status. This status obligates FDA to a goal of acting on the NDA within six-months from the date of submission. The FDA grants priority review status for new drugs that represent a significant advancement over available therapies. The NDA for Xyrem was submitted on October 2, 2000, to the FDA, which has sixty days from the date of submission to accept or reject it for review.
poster:MarkinBoston
thread:46036
URL: http://www.dr-bob.org/babble/20001022/msgs/47193.html