FDA
1st August 2013

FDA Panel Favors Nasacort OTC Switch

Innovative Science Solutions participated in the FDA advisory committee meeting Wednesday regarding whether to make the allergy nasal spray, Nasacort AQ (triamcinolone acetonide) made by French drugmaker, Sanofi, available without a prescription [e.g. over-the-counter (OTC)] to treat hay fever and other upper respiratory allergies.

FDA Panel Favors Nasacort OTC Switch

The RESULTS are in!

Innovative Science Solutions participated in the FDA advisory committee meeting Wednesday regarding whether to make the allergy nasal spray, Nasacort AQ (triamcinolone acetonide) made by French drugmaker, Sanofi, available without a prescription [e.g. over-the-counter (OTC)] to treat hay fever and other upper respiratory allergies.

The Nonprescription drugs advisory committee (NDAC) voted 10-6, with two members abstaining, in favor of switching triamcinolone, a corticosteroid, from prescription-only to being available for over-the-counter sales. However, several committee members expressed their concern about its use in children as there was a lack of data on widespread use in children in addition to concerns about the potential for corticosteroids to stunt growth.

“I voted No out of concern for inadequate data and duration of data to inform the growth issues, and I believe that the best way to address that is going to be through longer actual use studies and changes to the label,” said committee chair Richard Neill, MD, chief of family medicine at Penn Presbyterian Medical Center in Philadelphia. In this instance, the FDA didn’t require a self-selection or actual use study, which it sometimes requires in OTC switches.

Some panelists didn’t express the same level of concern with growth suppression.

Maria Pruchnicki, PharmD, professor at the Ohio State University College of Pharmacy in Columbus, voted Yes but also shared concerns about its use in patients under 18 because of potential growth issues.”I would like to see maybe a labeling change where healthcare providers can be a source of that information to patients, and maybe the company can focus on education efforts to highlight those areas of concern,” she said.

Other safety concerns such as nosebleeds, immunosuppression, glaucoma, and septal perforation  were noted by the FDA however, they expressed the fact that none of them are considered serious.

In addition, committee members expressed concern regarding how the product would be used over the counter and without supervision by a healthcare provider. Their concerns included overdosing, using the drug to treat colds, and consumers knowing when to stop taking the product. Other members were concerned people wouldn’t consult their physicians when taking the more risky corticosteroid as a nasal allergy spray.

Tramcinolone was approved in 1996 and is currently labeled for use in adults and children ages 2 and up. Nasal steroids also have been used safely for years when obtained via prescription, and there was no need to re-establish efficacy, FDA reviewers said.

If approved, Nasacort AQ would be the first intranasal corticosteroid to be sold over the counter in the United States. It is already sold over the counter in 10 countries.

The FDA isn’t obligated to follow the advice of its advisory committees, but usually does. Sanofi expects an FDA decision by this fall.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

 

Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself!

Generic Blog CTA for Ad Comm Approach

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us