Alas, a Cure for the Common Cold?
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?