Posted on 09/25/2003 12:14:45 PM PDT by aculeus
BETHESDA, Md., Sept 25 (Reuters) - A U.S. advisory panel on Thursday recommended approval of Cephalon Inc.'s (CEPH) drug Provigil to combat excessive sleepiness due to shift work or severe snoring that causes individuals to wake frequently.
But the Food and Drug Administration advisers split 4-4 on whether Cephalon should be allowed to market Provigil more broadly for excessive sleepiness from other sleep disorders.
The FDA usually follows the advice of its advisory panels.
Provigil already is approved for treating narcolepsy, a rare condition that causes uncontrollable sleeping during waking hours.
Trading in shares of West Chester, Pennsylvania-based Cephalon were halted during the FDA panel meeting.
Provigil's growing sales suggest the drug already is being prescribed beyond its approved use as word has spread that it can keep people awake and alert.
Doctors are free to prescribe medicines for any purpose once they are on the market.
Sales of Provigil rose 40 percent in the second quarter of 2003 to $69.5 million, from the prior-year period. The company acknowledges that most prescriptions likely are not written for narcolepsy.
The company said its studies showed Provigil, known generically as modafinil, helped shift workers and people with sleep apnea stay awake with mild to moderate side effects including headaches.
The FDA panel was unanimous in recommending Provigil for treating excessive tiredness caused by sleep apnea and voted 6-2 for its use in treating shift workers.
Provigil targets a part of the brain that controls sleep and waking, but researchers do not know exactly how it works.
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CEPH up $2, enough to buy a few cups of Folgers.
Seriously, some think this drug has blockbuster potential.
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