Alas, a Cure for the Common Cold?

From the WebMD Archives

March 26, 2001 (Washington) -- At first, it didn't seem possible. Then, there was a spark of hope that faded as rapidly as it was ignited. But now, it just may be a question of time before Americans finally get their hands on the first real cure for the common cold.

In the next few months, ViroPharma of Exton, Pa., is expected to file an application with the FDA to make and market a first-of-its-kind antiviral. Preliminary clinical results show that it may significantly decrease the duration and severity of the common cold.

Many treatments for the common cold are available. But this is the first time that a drug has been shown to alleviate the symptoms, decrease the severity, and actually help the patient get rid of viral particles that trigger the cold.

If the FDA approves the application, the drug could become available as early as 2002.

The antiviral, known as Picovir, prevents the replication of picornaviruses, a family of viruses that scientists believe cause more than 1 billion colds in the U.S. alone, resulting in about 51 million physician visits.

"Picovir really fills the need for an early treatment," Ellen Cooper, MD, vice president of clinical and regulatory affairs at ViroPharma, tells WebMD.

But despite the hype, bringing this drug to the market may be somewhat complicated.

In previous clinical trials, the results were not very promising. It was not until recently that the company could even demonstrate that the drug had a clinical benefit.

So what changed?

According to Cooper, the company simply was targeting the wrong patient population in studies of the drug.

"In the first trial, the portion of patients with picornaviruses was less than one-half," Cooper says. "In the current studies, that portion was increased to about two-thirds."

Once the right patient population was selected, the results became far more robust, Cooper points out. In the primary analysis, she observes, the treated patients experienced a benefit within 24 hours that lasted up to two days.

Still, this may raise a significant concern among government regulators. If the company had problems selecting the correct patients, what are the odds that physicians will not make similar mistakes?

"That is a problem," says Marianne Frieri, MD, a fellow of the American Academy of Allergy, Asthma, and Immunology. "There are other viruses with symptoms like a cold."

Also, at present there is no easy way to test for picornaviruses, notes the director of the allergy and immunology department at Nassau University Medical Center in East Meadow, N.Y. Therefore, she speculates, ViroPharma will need to demonstrate that there is a pressing need.

That could be a difficult task. Unlike many other viral infections, a cold often results in no permanent damage and disappears within a matter of days.

The saving grace is that physicians already prescribe antibiotics more often than not, although antibiotics are ineffective in treating viral diseases, Frieri says. Also, certain patients, such as those prone to asthma or bronchitis, may indeed have a pressing need for the experimental cold drug, she tells WebMD.

"The common cold is a frequent cause of bronchitis and asthma," Frieri says.

"Once educated, physicians will welcome the availability of an antiviral," Cooper says. "It fills the need for something other than an antibiotic."

Despite the hype of finding a cure for the common cold, a greater challenge might be convincing people that it is worth the price, Cooper says.

"It will really come down to the individual patient. Some people handle colds better than others," she says.

On the plus side, Cooper says, Picovir was very well tolerated -- with no real difference in terms of side effects between the drug and a sugar pill.

"It presents no real cause for concern," she tells WebMD.

For some people, that could make all the difference, Frieri agrees.

Although over-the-counter cold remedies, such as antihistamines combined with decongestants, may prove just as effective as Picovir, the over-the-counter combination may result in a temporary increase in blood pressure, Frieri says.

Down the line, though, the greatest benefit to this drug might be its ability to prevent someone from catching the common cold by preventing the cold virus from replicating in an otherwise unaffected individual, Frieri says.

Asked whether this is ViroPharma's ultimate goal, Cooper simply answers that other trials currently are being conducted in other patient groups.

"The idea for now is to reduce the morbidity [prevalence] of the [cold] itself," she tells WebMD.