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A sigh of relief for some ...
Provigil gets nod of approval
for sleep apnea, shift workers
By Dave Jackson
©
2003 by Awake In Philly. All rights reserved.
September 25, 2003 (2:50 p.m.) —
The U.S.
Food and Drug Administration's advisory panel that held hearings
on the use of Provigil (modafinil) for people with obstructive sleep
apnea, as well as people suffering shiftwork sleep disorders has tendered
its decision.
A unanimous vote was recorded by the Peripheral and Central Nervous System Drugs Advisory Committee, recommending
the use of Provigil
for treating excessive daytime sleepiness in people suffering
sleep apnea. The vote was split 6-2 in recommending the medication's
use for treating sleepiness in shift workers.
In testimony to the panel, Cephalon officials
said studies have shown that Provigil has offered benefits to shift
workers, as well as people who have been diagnosed with sleep apnea,
to stay awake. The company did report that there are mild to moderate
side effects associated with the medication, including headaches.
Provigil already is approved for treating narcolepsy,
a condition that causes uncontrollable sleeping during waking hours.
The military is interested in modafinil as a way
to have a soldier stay awake for a week at a time, a couple of studies
conducted by various organizations in the military are getting different
results. One study, conducted at Ft. Rucker, Alabama demonstrated
that modafinil bolstered the performance of sleep-deprived helicopter
pilots. On the flipside, however, there was a study conducted at the
Walter Reed Army Institute of Research, down in Silver Spring, Maryland,
that found six cups of coffee produce the same results on people as
modafinil does.
The panel was evenly divided over the use of modafinil
to treat sleepiness caused by other sleep disorders. That vote was
4-4.
According to Cephalon, sales for Provigil increased
by 40 percent in the second quarter of 2003, as compared with sales
during the second quarter of 2002. That increase in sales equated
to $69.5 million, and the company does acknowledge that most prescriptions
for Provigil were most likely to people not suffering narcolepsy.
Once a medication is approved for use in the United
States by the FDA, physicians are allowed to prescribed it for any
purpose. Cephalon, however, as the manufacturer, may market it only
as approved by the FDA.
The FDA usually follows the advice of its advisory
panels.
Contact Dave Jackson at:
PhillyAwake@scoop0901.net
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