Teva Pharmaceutical has announced positive results from four Phase 3 clinical studies of QNASL beclomethasone dipropionate HFA nasal aerosol for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Previously released data demonstrated that treatment with QNASL improved nasal symptom scores over the first 30 weeks of a 52-week study. The new data show significant improvement in nasal symptoms compared to placebo and a similar safety profile except for nasal bleeding, which occurred more frequently in the group treated with QNASL. A shorter, 6-week study showed improvement in quality of life compared to placebo.
Teva Global Respiratory Research and Development Senior VP Tushar Shah said, “Teva Respiratory is committed to the 20 percent of adults and adolescents suffering from allergic rhinitis in the U.S. and is hopeful that, if approved, QNASL will serve as a positive solution that helps allergy sufferers address and treat the bothersome symptoms of allergies. Based on the timing of the NDA acceptance and standard review timelines, we anticipate receiving FDA feedback on the approval status of QNASL in the near future.” The FDA accepted Teva’s NDA for QNASL in August 2011.
Allergist Gary N. Gross commented, “The long term data validated the efficacy and safety profile of QNASL and demonstrated positive results experienced by patients using the new ‘dry’ aerosol delivery. Since allergic rhinitis is one of the most common allergic diseases in the U.S., affecting more than one in five people, it’s important for there to be a variety of treatment options available to patients experiencing ongoing challenges with the condition.”
Read the Teva press release.
