|
I don’t
need that…I have my own things that keep me awake without medication…LOL From: [EMAIL PROTECTED]
[mailto:[EMAIL PROTECTED] On
Behalf Of Jen -- WASHINGTON (Reuters) -- A pill that helps people stay awake may be recommended for shift workers
and chronic snorers at a meeting of health advisers to be held Thursday.
Cephalon
Inc. is seeking Food and Drug Administration approval to expand the use of its
drug Provigil, which is currently only approved for narcolepsy, a rare disorder
marked by uncontrollable sleep during normal waking hours. West
Chester, Pennsylvania-based Cephalon says Provigil, which it described as
having gentler side effects than caffeine, is not intended as a quick fix for
sleep-deprived parents or college students cramming for an exam. "We're
not advocating this as a replacement for sleep. ... This is for when excessive
sleepiness is a medically disabling symptom of a serious underlying
condition," Dr. Paul Blake, Cephalon's senior vice president of clinical
research and regulatory affairs, said in an interview.
Cephalon
says it has conducted successful tests of Provigil on patients with narcolepsy,
shift workers and people with obstructive sleep apnea, a condition that leads
to collapse of the upper airway and frequent waking. An
FDA advisory panel Thursday will consider whether to recommend that the agency
approve Cephalon's request. The FDA usually follows the advice of its advisory
panels. FDA
staff told the advisers they had not completed their review of Cephalon's
application. "However,
we have reviewed the sponsor's description of the controlled trial data, and
are in general agreement with the results of their analyses," an FDA
official said in a memo for the advisers. FDA
staff also asked whether the studies would permit an assumption that Provigil
would be effective in combating jet lag and other forms of excessive
sleepiness. The
drug's sales already are rising rapidly. Provigil sales rose 40 percent in the
second quarter of 2003 to $69.5 million, from the prior-year period. Provigil
targets a part of the brain that controls sleep and waking but researchers do
not know exactly how it works, Blake said. Studies
showed Provigil, known generically as modafinil, improved alertness with mild
to moderate side effects including headaches and nausea, according to Cephalon.
Provigil is gentler than caffeine, which can make people shaky and jittery,
Blake said. "There's
no buzz or high that you get. ... It makes people feel relatively normal, alert
and wakeful, perhaps even surprising themselves how normal they feel," he
said.
|
<<image001.gif>>
________________________________
Changes to your subscription (unsubs, nomail, digest) can be made by going to http://sandboxmail.net/mailman/listinfo/sndbox_sandboxmail.net
