GSK Flonase Switch Application Coming? Actual-Use Study Underway

GlaxoSmithKline is actively considering the switch potential for Flonase with a trial evaluating consumers' ability to use the allergy nasal spray appropriately, according to the firm.

"We are assessing whether Flonase would be appropriate for OTC use," GSK said. Considerations include the safety of the drug and patient, physician and provider needs.

The firm has discussed its interest in an OTC switch for the nasal spray several times over the last three years as generic competition for the prescription product approaches.

Flonase's patent is set to expire May 14, 2004, including a six-month pediatric exclusivity extension, according to FDA's Orange Book.

Flonase is roughly a billion-dollar product for GSK. Worldwide sales for the six months ended June 30 were $522.6 mil., with the U.S. representing the majority, at $402.9 mil.

In the U.K., GSK has looked to bolster sales through the OTC marketplace. The firm was the first to take advantage of the relaxed U.K. OTC switch procedures, with a May 2002 request for Flonase. The product is currently sold in the U.K. without a prescription, but still under a pharmacist's guidance.

A U.S. advertising campaign kicked off earlier this year, in time for the fall allergy season, comparing Flonase to a number of OTC and Rx products. Television spots show a line of men wearing shirts with the names of various allergy remedies, including Schering-Plough's Claritin and Clarinex , as well as Aventis' Allegra .

"Sure all these OTC and prescription allergy medicines are approved for pollen," an announcer says. "But some are not approved for pet dander and dust. Others are not approved for smoke."

As the announcer lists indications for which the medications are not prescribed, the men representing different brands drop to the floor. "Only Flonase is approved to relieve the nasal symptoms from all these triggers," the ad continues. By the end of the spot, the only man standing wears the Flonase shirt.