Phase III Data For Teva’s QNASL® (beclomethasone Dipropionate) Demonstrate Efficacy Profile In Pediatric Patients With Seasonal Allergic Rhinitis

Teva Pharmaceutical Industries Ltd. announced today additional data from the Phase III clinical program for QNASL ^® (beclomethasone dipropionate) Nasal Aerosol, highlighting the drug’s efficacy profile in treating children (ages 6-11) with nasal symptoms of seasonal allergic rhinitis (SAR). QNASL ^® is a nonaqueous, “dry” nasal aerosol corticosteroid currently approved for the treatment of nasal symptoms associated with SAR and perennial allergic rhinitis (PAR) in patients aged 12 years and older. The data are being presented at the 2012 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Anaheim, CA. Additional data also presented at the ACAAI meeting reinforce the long-term ocular safety profile of QNASL ^® and the functionality and reliability of the device.

In a two-week, randomized, double-blind, placebo-controlled study, 715 patients with SAR, aged 6-11 years, received once-daily treatment with QNASL ^® 80 mcg, 160 mcg or placebo. The primary endpoint, the results for which were previously released ¹, showed significantly greater (p<0.001) improvement in nasal symptoms compared with placebo for both QNASL ^® 160 mcg and 80 mcg over the two-week treatment period. Additional data reported today further support the efficacy of once-daily dosing with QNASL ^®. The data show greater (p<0.001) improvements from baseline in patient-reported AM and PM reflective total nasal symptom scores (rTNSS) and patient-reported AM and PM instantaneous total nasal symptom scores (iTNSS) with QNASL ^® 160 mcg and 80 mcg as compared with placebo (p<0.01). Furthermore, physician-assessed nasal symptom scores (PNSS) show greater improvement in patients receiving QNASL ^®160 mcg and 80 mcg as compared with placebo (-.096, 95% CI: -1.4, -.05, P<0.001 [80 mcg]); (-.072, 95% CI: -1.2, -.02, P=0.004 [160mcg]). QNASL ^® was generally well-tolerated in children with a safety profile similar to that of placebo.

“QNASL is a much-needed treatment option for the millions of adults and adolescents suffering from the burdensome symptoms of allergic rhinitis,” said Dr. William Storms, MD, practicing allergist, clinical professor at the University of Colorado Health Sciences Center and founder of the William Storms Allergy Clinic in Colorado Springs, CO. “These data further showcase the drug’s safety and efficacy profile in treating the pediatric population and could prove beneficial to the 40 percent of children in the U.S. currently living with allergic rhinitis.”

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