Flonase: the journey from prescription to OTC

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

In the US, 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.

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 to consumers in the US as an over-the-counter medicine.

Why Flonase?

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).

In the case of Flonase, 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-recognize their symptoms.

Overall, we collected over 2000 volumes, 20GB 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 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 US.

The switch of Flonase 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-OTC weight loss aid.

Learn more about the process in interviews with team members who helped make it happen on our Tumblr.