Teva reports positive Phase III trials behind Qnasl, a nasal allergy treatment
JERUSALEM — Teva Pharmaceutical on Friday announced positive findings from a Phase III clinical study that examined the safety and efficacy of Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 g/day in children ages 4-to-11 years old with perennial — or “year round” — allergic rhinitis. In this pharmacy news, Qnasl is a waterless aerosol intranasal corticosteroid spray currently available for the treatment of PAR and seasonal allergic rhinitis in patients 12 years of age and older. The data will be presented at the 2014 American College of Allergy, Asthma & Immunology Annual Scientific Meeting in Atlanta on Nov. 8 and 9.
“As a company deep-rooted in its commitment to helping people living with respiratory conditions, such as allergic rhinitis, we look forward to the potential for bringing this new, specially formulated treatment option to market,” said Tushar Shah, SVP Teva Global Respiratory Research and Development. “It is our goal at Teva to address patients’ unmet needs, and we believe these findings support Qnasl as a prospective treatment for children suffering from the symptoms associated with nasal allergies.”
On May 13, 2014, the Food and Drug Administration accepted the supplemental new drug application for a lower dose Qnasl for the treatment of PAR and SAR in children ages 4-to-11 years old. The submission was based on a comprehensive clinical development program consisting of three Phase III clinical trials designed to evaluate the safety and efficacy of Qnasl80 g/day in children with allergic rhinitis. If approved, Qnasl will be the first and only waterless HFA nasal allergy treatment available for patients as young as four years of age.
“Since there are limited new treatment options available to help manage allergic rhinitis in the pediatric patient population, it is certainly exciting to see these results for Qnasl,” said study investigator William Berger of the Allergy and Asthma Associates of Southern California in Mission Viejo, Calif. “This treatment features a low-dose formulation and ‘waterless’ aerosol delivery, making it a promising option for children with allergic rhinitis.”