FDA Panel Gives Cold Shoulder to Cold Drug
Advisory group unanimously rejects pleconaril
TUESDAY, March 19, 2002 (HealthDayNews) -- An expert panel says the Food and Drug Administration should not approve an experimental compound that fights the common cold.
The drug, pleconaril, can cut the course of the common cold by about a day. But the panelists today said they weren't convinced of its safety and voted unanimously (15-0) to discourage FDA approval.
The panel's vote isn't binding on the agency, although the FDA generally follows its experts' recommendations.
Pleconaril, or Picovir, is being developed by ViroPharma Inc., of Exton, Pa., and Aventis Pharmaceuticals, of Bridgewater, N.J. It would be offered only in prescription form.
The manufacturers remain optimistic, despite the advisory panel vote.
Mark McKinlay, vice president of research and development for ViroPharma, said he expects Picovir to win approval once the company has a chance to discuss the safety issues with the FDA. "I don't believe they're insurmountable," he said.
The stumbling block, McKinlay said, was a six-week trial that showed women on oral contraceptives experienced spotting and bleeding while taking the drug. It appears to promote activity of an enzyme that hastens metabolism of the birth control hormones and might affect its interaction with other medications, he said.
Americans catch about a billion colds a year, or three-to-four per person, according to the National Institutes of Health (NIH). Roughly half of these are the result of infection with a group of microbes called picornaviruses, and in particular the rhinovirus branch of the family. In addition to causing colds, picornaviruses also trigger ear and sinus infections, as well as asthma and other lung symptoms.
Pleconaril works in two ways: It binds to picornaviruses, making them too rigid to pass into cells, and it prevents the ones that do penetrate their targets from releasing their genetic material.
Research has found that, when started within 24 hours of the onset of symptoms, a five-day course of pleconaril shortens the average cold from a week to six days. The drug can abbreviate bouts of respiratory discomfort, improve sleep and reduce the amount of over-the-counter cold remedies and tissues people use.
If the FDA were to reject its panel's advice, is a prescription cold pill what America needs?
"I can't say that it's useless, but it's not the first thing that you'd think of for expanding Medicare coverage," said Dr. Gerald L. Mandell, head of the division of infectious diseases at the University of Virginia in Charlottesville.
Ultimately, the question is not whether people need a cold drug, but how much they're willing to pay. Such is the case with many therapies.
Doctors "treat a lot of things that aren't life-threatening but improve a person's life," Mandell said. Headaches, for example, are unpleasant but not fatal, and people spend billions of dollars a year for relief from the pain.
What to Do: For more on colds, try the National Institute of Allergy and Infectious Diseases or the Centers for Disease Control and Prevention.