FDA to consider OTC approval of Singulair for adults only

The FDA’s Nonprescription Drugs Advisory Committee tomorrow will discuss a proposal to market prescription-only montelukast over-the-counter for the treatment of allergic rhinitis and other upper respiratory allergies to patients aged 18 years and older.

Montelukast sodium (Singulair, Merck) was first approved for prescription use in the United States in 1998 for the treatment of asthma in patients aged 15 years and older. It is currently approved for the treatment of prophylaxis and chronic treatment of asthma, acute prevention of exercise-induced bronchoconstriction and relief of symptoms of allergic rhinitis, seasonal allergic rhinitis, and perennial allergic rhinitis.

The proposed OTC dosing and indication for montelukast 10 mg tablets are similar to the dosing and indications currently approved by the FDA, with the exception that the manufacturer is seeking an additional ocular claim for the agent, according to FDA briefing documents.

The new indication would include, “temporarily relieves symptoms of hay fever or other respiratory allergies: nasal congestion, runny nose, itchy, watery eyes, sneezing, and itching of the nose,” according to the FDA documents.

Merck will present data from three previously conducted studies (Protocol 162, 192 and 235) in patients with seasonal allergic rhinitis to support their claim, the documents said.

Panel members will be asked to discuss the efficacy data for montelukast sodium, with emphasis on the new ocular indication. They also will be asked to assess the safety profile for OTC use, considering neuropsychiatric events, adequacy of proposed labeling regarding neuropsychiatric events, potential for off-label use and consequences of such use, and pediatric use.

The panel will be asked to vote on the risk and benefit profile of the drug with regard to its use in an OTC setting in adults with the nasal indication, “temporarily relieves these symptoms due to hay fever or other upper respiratory allergies,” according to the documents.

The drug’s most common adverse events include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.

For more information:

FDA Briefing Document: Nonprescription Drugs Advisory Committee Meeting, Montelukast (Singulair Allergy) – NDA 204804. Accessed May 1, 2014.