FDA Approves SINGULAIR(R) for Seasonal Allergic Rhinitis

Market Wire, 20050229

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the leukotriene blocker SINGULAIR(R) (montelukast sodium) for the relief of symptoms of seasonal allergic rhinitis (also known as hay fever). A convenient once-a-day tablet, SINGULAIR helps relieve a broad range of seasonal allergy symptoms for 24 hours. SINGULAIR is available to treat seasonal allergic rhinitis in adults and children as young as 2 years of age.

Most currently available oral allergy medications work by blocking histamine, one of several causes of allergy symptoms. SINGULAIR is a new and different way to treat seasonal allergies because it blocks leukotrienes instead of blocking histamine. SINGULAIR is the only medication indicated for seasonal allergic rhinitis that specifically targets this particular underlying cause of allergy symptoms. SINGULAIR should not be taken by people who are sensitive to any of its ingredients.

"Patients often associate allergic symptoms and allergic rhinitis with histamine, but there are actually a number of other factors - including leukotrienes - that are involved in the process," said Eli O. Meltzer, M.D., clinical investigator at the Allergy & Asthma Medical Group and Research Center, A.P.C., in San Diego, California. "SINGULAIR is the first agent available that specifically blocks leukotrienes to improve symptoms associated with seasonal allergic rhinitis."

SINGULAIR is available in tablet form for adults (10 mg) and as a cherry-chewable tablet (4 or 5 mg) for children aged 2-14 years.

The same SINGULAIR now approved to treat seasonal allergic rhinitis is also currently approved to help control asthma. SINGULAIR is the #1 prescribed asthma controller among allergists and pediatricians in the United States. (1) Since 1998, over 40 million prescriptions of SINGULAIR have been dispensed to patients. (2) SINGULAIR should not be used for the immediate relief of asthma attacks or to prevent or treat asthma made worse by exercise. Patients who have asthma made worse by exercise should continue to use their existing medications prior to exercise, unless instructed otherwise by their doctor.

Leukotrienes Connected to Seasonal Allergy Symptoms

Leukotrienes, substances produced by certain cells in the human body, trigger a number of effects that have been connected with symptoms of both asthma and allergic rhinitis. In intranasal challenge studies with pollen in patients with allergic rhinitis, leukotrienes have been associated with both the early and late stages of allergy symptoms; symptoms commonly experienced during the early stages of allergies include sneezing, nasal itching and runny nose; late stage symptoms include congestion. SINGULAIR has not been assessed in intranasal challenge studies. The clinical relevance of intranasal challenge studies is unknown.

"Merck is pleased that the FDA has approved SINGULAIR for use in seasonal allergic rhinitis," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck & Co., Inc. "This development provides a new therapy for the relief of allergy symptoms and expands the number of patients for whom SINGULAIR can be a useful treatment. Millions of people in the U.S. suffer from seasonal allergies."

SINGULAIR Helps Relieve a Broad Range of Seasonal Allergy Symptoms

In clinical trials, SINGULAIR was shown to be effective for relief of symptoms of seasonal allergic rhinitis. The efficacy of SINGULAIR 10 mg was evaluated in patients with seasonal allergic rhinitis, ages 15 to 82, in placebo- and active-controlled clinical studies. In clinical studies, SINGULAIR demonstrated effectiveness in improving daytime nasal symptoms score, the primary endpoint, measured as the average of individual scores of nasal congestion, rhinorrhea (runny nose), nasal itching and sneezing. A secondary endpoint, nighttime symptoms score (the average of individual scores of certain nighttime symptoms), was also evaluated and was supportive of the efficacy seen with the primary endpoint.

Safety Profile of SINGULAIR in Seasonal Allergic Rhinitis Studies Generally Similar to Placebo

In clinical trials for allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo and was not associated with sedation, a common side effect of several allergy medications. In studies of SINGULAIR, the most commonly reported side effects were headache, ear infection, sore throat and upper respiratory infection.

Important Information about SINGULAIR for the Treatment of Asthma

The use of SINGULAIR for patients with asthma may not eliminate the need for inhaled or oral corticosteroids. Patients should not decrease the dose or stop taking other asthma medications unless instructed by their doctor. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR.

In clinical trials for asthma, adverse experiences were generally mild and varied by age. The most common adverse experiences in patients with asthma included headache, flu, runny nose, ear infection and upper respiratory infection.