Generic drugmaker Teva Pharmaceutical Industries Ltd. (TEVA) on Monday said the U.S. Food and Drug Administration has approved Qnasl Nasal Aerosol, a new, dry nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents who are 12 years old or above.
The approval was based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years of age and older.
Allergic rhinitis is the most common allergic disease in the U.S. It affects more than one in five people, causing some to have symptoms year round and others to experience symptoms during specific times of the year.
The safety and efficacy of Qnasl Nasal Aerosol was demonstrated in four, Phase III trials, where patients received Qnasl 320 mcg once-daily administered as two sprays in each nostril.
Intra-nasal corticosteroids are recommended as first-line therapy for allergic rhinitis and the only available option on the market before the approval of Qnasl (beclomethasone dipropionate) were aqueous formulations.
The product is expected to be available by prescription in April. It will be the first marketed non-aqueous or dry nasal aerosol in a product category that reports annual sales of $2.5 billion.
Qnasl is delivered as a once-daily, pressurized, hydrofluoroalkane or HFA-propelled non-aqueous aerosol that is environmentally friendly and offers a built-in dose counter.
Gary Gross, practicing allergist and co-founder of the Dallas Asthma and Allergy Center, said, "There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies. The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery."
Teva shares, which closed at $43.07 on Friday, are adding 2.1 percent in pre-market activity.
by RTT Staff Writer
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