In a unanimous decision, an FDA advisory committee recently determined that phenylephrine, a key ingredient in popular over-the-counter nasal decongestants, is no more effective than a placebo in treating cold and allergy symptoms. The committee reviewed mounting evidence indicating that oral phenylephrine is an ineffective remedy for nasal congestion, even though many consumers use products that contain it, such as Sudafed PE and NyQuil. In response, CVS retail pharmacies discontinued the sale of products containing oral phenylephrine as the sole active ingredient. Although phenylephrine gained FDA approval for over-the-counter use in 1976, evaluation criteria have evolved. The FDA now relies on clinical symptom scores, where patients rate nasal symptom severity, as the gold standard for evaluating efficacy. On this scale, phenylephrine falls short. Studies since 2007 have consistently shown no difference between phenylephrine and a placebo, often attributed to the finding orally administered phenylephrine is deactivated in the digestive system.
And the bottom line is what now? The phenylephrine market size was valued at $777.6 million last year.