Schering-Plough Announces NASONEX Nasal Spray for Children as Young as 3 Years of Age
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(NYSE: SGP) today announced that NASONEX(R) (mometasone furoate
Nasal Spray 50 mcg has received marketing approval from the U.S. Food and
Administration (FDA) for the treatment of the nasal symptoms of seasonal
perennial allergic rhinitis in children as young as 3 years of age.
is the only drug in its class to be indicated for children as young as
NASONEX is currently marketed for the treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adult and adolescent patients 12 years and older. It is also approved for the prevention of nasal symptoms of seasonal rhinitis in adult and adolescent patients 12 years and older, and is the only nasal inhaled steroid approved in the United States for this indication.
The new approval follows the FDA's review of clinical trials specifically designed to evaluate the safety and efficacy of NASONEX Nasal Spray in pediatric populations and represents the youngest indication for any prescription nasal inhaled corticosteroid.
"A growing child has medical considerations quite different from those of a mature adult," said Eric J. Schenkel, M.D., director, Valley Clinical Research Center, Easton, Pa. "Assumptions about pediatric pharmacology should be validated in clinical studies that account for the developmental stages of a child. This approval demonstrates that NASONEX is a safe and effective medicine for treating allergies even in children as young as age 3," he said.
Allergic rhinitis affects more than 6 million children each year and accounts for 2 million missed school days, with indirect costs reaching $4 billion. Day care centers and schools are environments where exposure to allergens such as dust mites, mold and pet dander carried from home on children's clothing can be particularly high.
The FDA in 1998 reviewed data that some nasal corticosteroids may have an adverse effect on growth in children, but it is uncertain whether there is a long-term effect on ultimate height or whether all nasal steroids have such an effect. In support of this newest indication for NASONEX for young children, long-term clinical studies were conducted that showed no statistically significant effect on growth velocity in children ages 3 to 9 compared to placebo. Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including NASONEX, should be monitored routinely (e.g., by stadiometry).
NASONEX has a virtually undetectable level of absorption into the bloodstream. The overall incidence of adverse events was comparable to placebo and did not differ significantly based on age or sex. The most commonly reported adverse events, not necessarily drug-related were, for NASONEX and vehicle placebo, respectively: headache (17 percent vs. 18 percent), viral infection (8 percent vs. 9 percent), pharyngitis (10 percent vs. 10 percent), epistaxis/blood-tinged mucus (8 percent vs. 9 percent) and coughing (13 percent vs. 15 percent).
The usual recommended dose of NASONEX Nasal Spray for children 3 to 11 years of age is one spray (50 mcg per spray) in each nostril once daily. For adults and children 12 years of age and older, the usual recommended dose is two sprays (50 mcg per spray) in each nostril once daily. NASONEX is available nationwide by prescription only.
Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
CONTACT: Media - Robert J. Consalvo, 973-822-7409, Investors - Geraldine U. Foster, 973-822-7410, Janet M. Barth, 973-822-7417, or Alexandra Sproul, 973-822-7483, all of Schering-Plough Corporation
Dec. 2, 1999