FDA approves Qnasal as AR treatment
The FDA has approved Teva Pharmaceutical Industries' Qnasal (beclomethasone dipropionate) nasal aerosol, a "dry" nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. The product is expected to be available in the US by prescription in April 2012 and will be the first marketed non-aqueous nasal aerosol in a product category that records annual sales of US$2.5 billion. Qnasal is delivered as a once-daily, pressurised, hydrofluoroalkane (HFA)-propelled nonaqueous aerosol that offers a built-in dose counter.
The approval is based on a comprehensive clinical development programme that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adolescent and adult patients 12 years of age and older. The safety and efficacy of Qnasal was demonstrated in four Phase III randomised, double-blind, parallel-group, multicentre, placebo-controlled trials. In these trials, patients received Qnasal 320mcg once-daily administered as two sprays in each nostril.