FDA advisers vote 10-6 in favor of Nasacort AQ as an OTC

SILVER SPRING, Md. — Sanofi Wednesday evening announced that the Food and Drug Administration's Nonprescription Drugs Advisory Committee voted 10-6 in favor of its switch application of the nasal corticosteroid Nasacort AQ. Two committee members abstained. 

"Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," stated Charles Hugh-Jones, chief medical officer, Sanofi US. "We appreciate the feedback from the committee and look forward to working with FDA in completing its review."

If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi's consumer healthcare division, Chattem. The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies (allergic rhinitis) in adults and children 2 years of age and older.

"The OTC availability of Nasacort would continue to build on Chattem's highly successful OTC launch of Allegra and further expand our consumer healthcare offering," commented Anne Whitaker, president, North America Pharmaceuticals, Sanofi.

The concern of the committee members who voted against the proposed switch was use of the product in children — there is a concern that Nasacort AQ could inhibit growth in pediatric populations. Nasacort AQ is presently approved for use in children over the age of two and adults. At least one committee member suggested a dual status like that of Plan B, which before June was available over-the-counter to adults but by prescription-only to girls younger than 17. (In June, the FDA approved the use of the emergency contraceptive OTC without restrictions.)

The allergy reliever was initially approved in 1996. The lack of any serious adverse events associated with the medicine was cited by some on the panel who voted for the switch. The FDA did identify other safety concerns — including nosebleeds, immunosuppression, glaucoma and septal perforation — but acknowledged that these incidents were rare. 

Chattem's proposed labeling tested well. In a study of 475 consumers, 96.6% understood instructions in the proposed label to tell their child's doctor when a child starts using the product. However, only 3-in-4 (78.7%) understood instructions that the medication may temporarily slow the rate of growth in some children.