Flonase® Allergy Relief Rx-to-OTC Switch

Switching a product from a prescription medicine to over the counter (OTC) is nothing to sniff at

In the United States, some 50 million people suffer from serious nasal allergies and an estimated 70% of them treat their symptoms with prescription or OTC treatments. However, half of these sufferers report they are not completely satisfied with their current method of prescription treatment. We want to do what we can to make it easier for patients and consumers to access a proven treatment that works for them.


allergy sufferers in the US use OTC treatments

We’re improving access to a proven medicine

That’s why we have spent time and resources to make one of our most popular prescription medicines, now called Flonase® Allergy Relief, available to those with allergies at the same strength but without a prescription.

We have a strong heritage—40 years—in discovering and developing respiratory products used by patients worldwide. We’ve used this heritage and scientific strength to now bring prescription Flonase® Allergy Relief to consumers in the United States as an over-the-counter medicine.

Why Flonase® Allergy Relief?

But not every medicine is able to be sold without a prescription. Switching a product from prescription to over the counter involves gathering tremendous amounts of scientific data for submission to the US Food & Drug Administration (FDA).

Half of allergy sufferers report they are not completely satisfied with their current method of prescription treatment

In the case of Flonase® Allergy Relief, the process involved gathering data from approximately 43 clinical studies, postmarking data involving more than 31.2 million “patient years” of experience with the medicine and involving numerous teams from our pharmaceutical and consumer healthcare businesses working together to make sure that the data is comprehensive and meets today’s standards.

In addition, it was vital to show that the product has an acceptable risk-benefit profile for patients to take on their own without a doctor’s supervision and that nasal allergies are a condition where patients can self-recognise their symptoms.

Overall, we collected over 2000 volumes, 20 GB of data and an estimated 600,000 pages of data as part of our submission to the FDA to “switch” the product from prescription to over the counter.

Finally, in July 2014, the FDA approved Flonase® Allergy Relief for temporary relief of the symptoms of hay fever or upper respiratory allergies, and the product is now available at full prescription strength in stores in the United States.

The switch of Flonase® Allergy Relief OTC is the latest example of successful switches for GSK Consumer Healthcare that have included widely-used products like GSK’s Smokers’ Health brands, Nicorette® Gum and NicoDerm CQ® Patch, as well as alli®, the only FDA-approved OTC weight loss aid.