FDA approves lower dose QNASL for Allergic Rhinitis-Teva Pharma

The FDA has approved QNASL (beclomethasone dipropionate) 40 mcg, from Teva Pharma, for the treatment of nasal symptoms associated with Allergic Rhinitis (AR) in children 4-11 years of age. QNASL 40 mcg is a lower dose formulation of QNASL Nasal Aerosol (80 mcg), a waterless (non-aqueous) intranasal corticosteroid (INS) spray currently available by prescription for adults and adolescents (12 years of age and older) for the treatment of nasal symptoms associated with AR.

QNASL 40 mcg delivers effective symptom relief at one-fourth of the dosage approved to treat adults and is the first and only waterless hydrofluoroalkane (HFA) nasal allergy treatment to be approved for use in patients as young as four years of age. The drug is expected to become available by prescription in February 2015.

FDA approval was based on data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL 40 mcg in children (ages 4-11) with AR. Data demonstrated that once-daily treatment with QNASL 40 mcg provided significant nasal allergy symptom relief in children with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in comparison to placebo. In all three studies, the safety profile of QNASL 40 mcg was similar to that of placebo and the most common adverse events were nosebleeds and ulcers, which is consistent with those seen in previous clinical studies of QNASL Nasal Aerosol.