The QNASL nasal spray, approved in 2012 for adults, treats nasal symptoms of allergic rhinitis, including hay fever, in children.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration (FDA) has approved the 40 mcg version of its QNASL nasal spray for the treatment of nasal symptoms associated with allergic rhinitis (AR) (allergies including hay fever) in children aged 4-11.
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QNASL 40 mcg is a lower dose formulation of QNASL Nasal Aerosol (80 mcg), currently available by prescription for adults and adolescents (12 years of age and older) for the treatment of allergies, which was approved by the FDA in 2012. 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.
“The approval of QNASL for use in children aged 4-11 is an important advancement for an often difficult-to-treat patient group, ” said Dr. Todd Mahr, MD, Director of Pediatric Allergy and Immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin. “QNASL 40 mcg has several characteristics that provide prescribers with a treatment option specifically designed for children with allergic rhinitis, including its ‘waterless’ aerosol method of delivery and lower dose formulation.”
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.
Teva Global Respiratory R&D VP Dr. Tushar Shah said, “The approval of this lower dose formulation of QNASL for children reaffirms Teva’s deep-rooted commitment to developing treatment options to help address respiratory conditions among all patient populations. Through the availability of QNASL 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies.”