New Study Shows Over-the-Counter Decongestant Effective

Trade Group Files New Data with FDA, Study Refutes Earlier Criticism

WASHINGTON, D.C. (February 13, 2007)—A new meta-analysis shows that phenylephrine, a popular decongestant in many over-the-counter cold and allergy remedies, is effective at relieving nasal congestion. The results confirm the assertion by the U.S. Food and Drug Administration on the efficacy of phenylephrine at a 10-milligram dose. Results of the new study were filed last week with FDA by the Consumer Healthcare Products Association, which conducted the analysis.

"Phenylephrine has been relieving people’s congestion for decades, and this meta-analysis reaffirms that," said CHPA President Linda Suydam, D.P.A. "The FDA has ruled that phenylephrine is safe and effective based on its own thorough review; we now add this critical meta-analysis to its files to further support that ruling."

This meta-analysis refutes the contention that phenylephrine in its 10-milligram dose does not provide effective nasal decongestion. Last July, a Florida pharmacist made that assertion in a letter to the editor of a medical journal. He since has called on FDA to raise the standard dose to 25 milligrams and require further studies of the higher dose’s safety and efficacy.

The new meta-analysis was performed on seven efficacy studies of phenylephrine that had a similar design. It showed phenylephrine to be significantly more effective than placebo at relieving congestion at the primary time points measured – 30 and 60 minutes post-dose – and at 90 minutes post dose. It was designed to provide an accurate representation of phenylephrine’s effectiveness over time, focusing on the highest efficacy in the first hours.

"We used a particularly conservative methodology to ensure we held phenylephrine to the toughest standards when measuring effectiveness," said Dr. Heinrich Schneider, vice president of regulatory and scientific affairs for CHPA. The design was guided and vetted by expert biostatisticians from Georgetown University and Kansas State University, and conformed to FDA guidance.

The study methodology also was designed for maximum relevancy: it measured when the medicine started to work and for how long, which is exactly what people suffering from nasal congestion need to know.

Contacts: Elizabeth Assey and Virginia Cox, 202.429.9260 w) 202.256.5677 (m)

CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.