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Monday February 23, 7:14 am Eastern Time
Company Press Release
SOURCE: Merck & Co.
Merck's Singulair(R), A New Option in Asthma Treatment,
Approved by FDA; Once-A-Day Pill Approved for Both Adults
and Children from Age Six
WEST POINT, Pa., Feb. 23 /PRNewswire/ -- An important therapeutic option has arrived for the nearly
10 million adults and five million children in America who live with the distressing disease of asthma, as the
U.S. Food and Drug Administration has cleared for marketing Singulair(R) (montelukast sodium), a new
once-a-day pill for the prevention and chronic treatment of asthma.
Of the new class of asthma medicines called leukotriene blockers, Singulair is the first intended for both
adults and children as young as six, and the first developed for once-daily use. Singulair works by blocking
leukotrienes, powerful substances that are involved in the inflammatory process associated with asthma.
Singulair has been studied for the long-term control of asthma, but is not intended for the relief of acute
asthma episodes or symptoms. It should not be used to relieve an asthma episode or be abruptly
substituted for oral or inhaled corticosteroids. Patients should have quick-relief medicines available to treat
worsening asthma.
''For anyone, but particularly for a child, having asthma can be devastating. Not only is asthma extremely
limiting, but the child must also learn to use inhalers and other special equipment to take his or her medicine.
Often they must remember to do it several times a day. Singulair may simplify the burden of asthma control,
especially for many asthmatic children and their parents,'' said Beth Seidenberg, M.D., Executive Director,
Clinical Research, Merck Research Laboratories.
In clinical studies, Singulair improved asthma control in many patients by significantly decreasing asthma
attacks, preventing daytime and night-time asthma symptoms, and reducing reliance on other asthma
medicines, such as quick-relieving bronchodilators. It also allowed many patients to reduce gradually their
use of inhaled steroids. Inhaled steroids are the most commonly used drugs for long-term asthma control,
but they can be difficult to use and have been associated with potential side effects, particularly at high
doses and with long-term use. However, Singulair may not completely eliminate the need for inhaled or
systemic corticosteroids. Patients should not decrease or stop taking other asthma medicines unless
instructed by their doctor.
Singulair is not a steroid and in clinical studies was as well-tolerated as placebo, or a sugar pill. It will be
available in pharmacies by mid-March as both a 10 mg tablet for adolescents and adults and a 5 mg
cherry-flavored chewable tablet for children ages 6 to 14.
''With the prevalence of asthma continuing to rise -- especially in children -- physicians urgently need new
treatments to help patients stay on therapy and give them greater control over this alarming and sometimes
life- threatening disease,'' said Stanley J. Szefler, M.D., Director, Medical Pharmacology, National Jewish
Medical Research Center, Denver. ''As a once-a- day treatment, Singulair may improve asthma control for
many patients depending on the severity of the disease.''
Singulair(R): Playing a Role in Asthma Control
The marketing clearance of Singulair is based on clinical studies that measured efficacy and safety in more
than 3,000 adults and children, aged six to 14 years.
''Our goal was to develop a once-a-day medicine that was both effective and well tolerated, providing
chronic asthma patients with a new way to help control their disease,'' said Dr. Seidenberg. ''First,
physicians can start Singulair for patients not controlled solely by as-needed quick-relief medicines
(bronchodilators). Also, they can add Singulair to the regimens of patients who aren't controlled completely
on daily inhaled steroids. For those patients who are controlled on high doses of inhaled steroids, they can
use Singulair to decrease the dosage of inhaled steroids while still maintaining asthma control. And very
importantly, Singulair provides a simple, well-tolerated, effective and steroid-free treatment option for kids
as young as six.''
Singulair should be taken in the evening and may be taken with or without food.
Side Effects Uncommon
Side effects with Singulair were usually mild and generally did not require patients to stop taking Singulair.
Side effects seen in adults and children during the clinical trials were similar for the groups treated with
Singulair and for those treated with placebo. The most commonly reported side effects in adults for both
placebo and Singulair were headache, influenza and abdominal pain. There was no increase in side effects
with extended treatment, and no clinically meaningful drug interactions.
Patients should take Singulair daily as prescribed even when they have no symptoms, as well as during
periods of worsening asthma. Singulair should not be used to relieve an acute asthma episode.
Singulair should not be used by itself for the treatment and management of exercise-induced asthma.
Patients should be advised to continue using their usual regimen of bronchodilators before exercise.
Singulair(R) Improves Asthma-Related Outcomes
In clinical trials, 81 percent of adult patients taking Singulair reported that they felt better (vs. 67 percent
taking placebo and as-needed bronchodilators), and 81 percent of parents reported that their children
(aged 6-14 years) with asthma felt better (vs. 71 percent taking placebo and as- needed bronchodilators).
Asthma-related outcomes for adults and adolescents (15 and older) with mild to moderate asthma taking
Singulair improved significantly. When compared to placebo and as-needed bronchodilators, an analysis of
1,325 patients (795 on Singulair and 530 on placebo) showed that patients treated with Singulair and
as-needed bronchodilators:
Suffered 37 percent fewer asthma attacks (11.6 percent in the group treated with Singulair vs. 18.4
percent in the placebo group). Asthma attack was defined as an emergency room visit, hospital
admission, unscheduled doctor's office visit or a need for treatment with oral, intravenous or
intramuscular corticosteroids. |
