The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.
“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.
The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.
QNASL40 mcg is expected to become available in February 2015.
