FDA approves nasal spray for kids ages 2 to 5

September 25, 2008

The U.S. Food and Drug Administration (FDA) has approved triamcinolone acetonide for sneezing, runny nose, and congestion caused by allergic rhinitis in pre-schoolers, according to the manufacturer Sanofi-aventis.

The U.S. Food and Drug Administration (FDA) has approved triamcinolone acetonide for sneezing, runny nose, and congestion caused by allergic rhinitis in pre-schoolers, according to the manufacturer Sanofi-aventis.

The nasal spray, called Nasacort AQ, was tested in a randomized, double-blind, placeb-controlled trial of 464 children with allergic rhinitis. One spray per nostril daily for four weeks showed that while the instantaneous reduction in the primary endpoint, Total Nasal Symptom Score (TNSS), was not significant, triamcinolone did significantly reduce TNSS at 24 hours.

In addition, 50.8% of participants receiving treatment and 48.3% of participants receiving placebo experienced adverse events, the most common of which was cough (cough rates: 7.6% in treatment group, 9.2% in placebo), followed by pyrexia and headache.