FDA
5th May 2014

FDA Panel Recommends Against OTC Use of Singulair Allergy

During this meeting on Friday, May 2nd, the Nonprescription Drugs Advisory Committee (NDAC) discussed data submitted by MSD Consumer Care, Inc. (Merck).

FDA Panel Recommends Against OTC Use of Singulair Allergy


During this meeting on Friday, May 2nd, the Nonprescription Drugs A
dvisory Committee (NDAC) discussed data submitted by MSD Consumer Care, Inc. (Merck), to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is for the treatment of allergic rhinitis (AR). It’s intended to be used for the temporary relief of nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose. The applicant proposed to label the product for OTC use in adults 18 years and older.

In this meeting, there were two voting questions and two discussion questions. For the voting question regarding whether the safety of OTC use of montelukast sodium for relief of allergy symptoms, considering potential off-label use, had been adequately demonstrated, 11 panelists voted no and 4 voted yes.

The voting results were identical for the second question regarding whether the risk/benefit profile of montelukast sodium was supportive of OTC use in adults for the nasal indication (i.e. “temporarily relieves these symptoms due to hay fever or other upper respiratory allergies”).

Notably, a study submitted by Merck involved adolescents ages 15 to 17 showed that too many teens thought it was right for them to use, despite labeling only for adults. Additionally, a label comprehension and self-selection study was performed in adults with allergic rhinitis, and showed that nearly all understood the warnings about changes in mood, behavior, or thoughts or changes in sleep that the FDA has warned about with this class. Both questions met the 90% threshold for lower bound. The self-selection part of the study showed that the majority of patients correctly selected themselves for use by allergic rhinitis status, but the target of at least 90% correct answers (as a lower bound) wasn’t met for understanding that the drug should not be used to treat asthma.

NDAC committee chair Ruth M. Parker, MD, professor of medicine at Emory University School of Medicine in Atlanta, Georgia, summarized the reasons for resistance to making Singulair available OTC includes the risk of the drug being used off-label and the complexity of the label being too difficult for the average adult to fully understand.

Montelukast has been a prescription medicine for the treatment of asthma for children and adults since 1998, for seasonal AR since 2002, for perennial AR since 2005, and for exercise-induced bronchoconstriction since 2007. If approved, Montelukast would be the first in the leukotriene receptor antagonist class to make the switch from prescription to OTC.

Current OTC treatments for allergic rhinitis include oral antihistamines, oral combinations of an antihistamine and decongestant, intranasal decongestants, intranasal cromolyn, and an intranasal corticosteroid.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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.

Do you have an upcoming Advisory Committee Meeting?

White Oak Gude

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