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FDA approves waterless nasal spray for treatment of allergy symptoms in children

The FDA approved beclomethasone dipropionate 40 mcg to treat children aged 4 to 11 years suffering from nasal symptoms associated with allergic rhinitis, according to a press release.

QNASL (beclomethasone dipropionate) 40 mcg — a lower dose formulation of QNASL Nasal Aerosol (80 mcg) — is a waterless intranasal corticosteroid spray manufactured by Teva. The spray is available by prescription for adults and children over the age of 12 for the treatment of nasal symptoms associated with allergic rhinitis.

“The approval of QNASL for use in children aged 4 to 11 is an important advancement for an often difficult-to-treat patient group,” Todd Mahr, MD, director of Pediatric Allergy and Immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin, said in the press release.

QNASL 40 mcg was evaluated in three double-blind, placebo-controlled studies in children aged 4 to 11 years with allergic rhinitis. The primary outcome of each study indicated a once-daily treatment with QNASL 40 mcg provided significant nasal allergy relief in children with significant allergic rhinitis and perennial allergic rhinitis compared with placebo.

The most common side effects associated with QNASL 40 mcg were nosebleeds and ulcers, which were consistent with what was seen in previous clinical studies of the stronger QNASL Nasal Aerosol.

The new dosage formulation is expected to become available by prescription in February 2015, according to the press release.