Scientists Improve on Cold Medicine
Published 7:00 pm, Monday, December 17, 2001
AP Medical Editor
In a medical first, researchers have developed a drug that speeds recovery from the common cold _ a significant breakthrough for scientists who have been in pursuit of a cure for decades.
Since the medicine doesn't make the sniffles disappear immediately, it is still debatable whether the scientists have discovered the long-sought cure. But experts have little doubt about its importance.
The drug _ which is still months away from drugstores _ eases cold symptoms within a day and makes a runny nose completely clear up a day sooner than usual.
Experts say that is a substantial development _ considering a one-day reduction in a viral disease that lasts only a few days is probably the best that can be hoped for.
The findings were presented Monday by Dr. Frederick Hayden of the University of Virginia at an infectious-disease conference in Chicago sponsored by the American Society for Microbiology. The research was financed by ViroPharma Inc. of Exton, Pa., which is developing the drug.
The company applied in July to the Food and Drug Administration for approval to market the drug. A decision is at least months away.
Experts say they expect the agency to be unusually cautious, since any medicine to treat a non-lethal infection in healthy people must be extremely safe.
"The safety issues are dramatic," said Dr. Scott Hammer, a virus expert at Columbia University. "They will be looked at very, very carefully."
Hayden said he has seen no significant side effects from the drug, called pleconaril. Some volunteers have a slight, temporary rise in cholesterol levels, which he said has "no clinical significance."
The company has not said how much it will charge for the medicine, which would be sold by prescription under the brand name Picovir, but officials said it is likely to cost as much as antibiotics, which typically are more than $40 for a course of treatment.
Unlike many over-the-counter remedies, which ease cold symptoms by drying up plugged noses and soothing aches, pleconaril attacks a large group of viruses known as the picornaviruses. Among these is the rhinovirus, the bug that causes about half of all colds.
"It really represents the first effective treatment for a rhinovirus illness," Hayden said.
The medicine stops the virus by fitting into a groove on its surface. This jams the machinery it needs to enter and infect the body's cells.
The latest research is ViroPharma's second attempt to prove that the drug speeds recovery from the common cold. Its earlier study fell short of showing a statistically significant benefit.
In the latest work, conducted a year ago, people who felt colds coming on were randomly assigned to get pleconaril or dummy pills. In all, 2,096 people started in the study within a day of the onset of symptoms.
Testing showed that two-thirds of the volunteers actually had caught a rhinovirus. In these people, runny noses and other symptoms completely went away in an average of six days, compared with seven days in the rhinovirus sufferers getting placeboes.
Volunteers were allowed to take their usual over-the-counter medicines. Nevertheless, those using pleconaril began to feel better than the others within a day of starting treatment. Their symptoms were half gone in three days, compared with four days among those getting dummy pills.
New studies are under way to test the drug in children who have colds as well as in college students to see if it will keep them from catching colds.
Those with fevers were excluded from the study, since their colds are unlikely to result from rhinoviruses.
In general, Hayden said the medicine is likely to be most useful in the spring, summer and fall, when the rhinovirus is the dominant cause of colds. Colds in the late fall and winter are more likely to result from other viruses.
Doctors assume that the sooner people start taking the drug, the better their chances of cutting short their colds. Hayden said pleconaril may work best if people keep a supply at home to use at the first telltale symptoms.
Colds are the single most frequent reason why people go to the doctor. Antibiotics are worthless against colds, though doctors often prescribe them anyway.
An FDA advisory panel is scheduled to review pleconaril next spring. Hayden declined to predict whether it will be approved. However, he said, "I would certainly use it, and I would use it in my family members."
Pleconaril may also work against other kinds of picornaviruses, including ones that causes viral meningitis and middle-ear infections.
Medical Editor Daniel Q. Haney is a special correspondent for The Associated Press.
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