FDA Decision Alert
The FDA
Peripheral and Central Nervous System Advisory Committee is scheduled
to meet on Wednesday to provide recommendations on the use of Orphan Medical’s
(
ORPH |
Quote |
Chart |
News |
PowerRating)
new drug Xyrem to treat narcolepsy.
Recent clinical data has demonstrated
noticeable improvement in the sleep patterns in patients with narcolepsy, in
addition to a reduction in the daytime sleepiness so characteristic of the
disease. The drug seems to be well tolerated in patients and has an acceptable
safety profile — both favorable factors for the Advisory Committee to consider.
 Â
The market for narcoleptic and
fatigue-fighting drugs is expanding and Orphan Medical’s new treatment should
provide some needed competition to Cephalon’s
(
CEPH |
Quote |
Chart |
News |
PowerRating) anti-narcoleptic drug, Provigil. The FDA Advisory
Committee’s upcoming decision is crucial to bringing this drug to market by the
end of the year and will greatly impact the company’s future revenue
projections. Â Â