A drug intended to attack viruses that cause the common cold is up for review.On Tuesday, advisors must decide whether to approve the experimental medication.
Picovir, made by ViroPharma Inc. and co-developed with Aventis SA, unique inits function, directly targets the common cold viruses.
Other over-the-counter drugs suppress the common cold symptoms, but are ineptat inhibiting the actual virus activity.
‘[Picovir] causes more rapid reductions in the severity of multiple coldsymptoms, begging within one day of initiation of treatment,’
ViroPharma stated in documents prepared for Tuesday’#146;s meeting of a Foodand Drug Administration (FDA) advisory panel.
Pharmaceutical industry analysts were divided over whether studies demonstrateenough of a benefit for the drug to win FDA’#146;s approval.
The most recent privately sponsored research showed that colds treated withPicovir cleared up about a day faster than they normally would.
FDA and ViroPharma will present evaluations to a group of experts from outsidethe agency. Winning the panel’#146;s support is necessary in order to marketthe drug.
An improvement of one day was sufficient in recent years for FDA approval oftwo influenza drugs.
As far as Picovir goes, patients need to start taking the drug soon after symptomsstart. Treatment lasts five days, with three daily doses. If approved by theFDA, the drug would be available by prescription only.
Because the common cold normally is not life-threatening, the FDA and the panelare expected to inspect Picovir’#146;s safety even more closely.
A preliminary review by FDA staff, released ahead of the meeting, noted varioussafety concerns.
One of these was a higher rate of menstrual disorders in women treated withPicovir while taking oral contraceptives.
‘There’#146;s a lack of clarity as far as whether the product works ornot,’ Ira Loss of Washington Analysis said before the meeting. ‘Interms of having a classic demonstration of safety and efficacy that you normallysee in products that get approved, I think it’#146;s lacking.’
