During this meeting on Friday, May 2nd, the Nonprescription Drugs Advisory 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.

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