FDA approves Teva's QNASL nasal aerosol corticosteroid

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved QNASL^TM Nasal Aerosol, a new, "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 by prescription in April 2012 and will be the first marketed nonaqueous or "dry" nasal aerosol in a product category that reports annual sales of $2.5 billion. QNASL^TM is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly and offers a built-in dose counter.

“The approval of QNASL is a significant milestone for Teva Respiratory and represents our commitment to addressing the unmet needs of millions of Americans suffering from allergic rhinitis”

"There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies," said Gary N. Gross, MD, FACAAI, practicing allergist and co-founder of the Dallas Asthma and Allergy Center. "The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery."

The approval of QNASL^TM Nasal Aerosol is based on a comprehensive clinical development program 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 QNASL^TM Nasal Aerosol was demonstrated in four, Phase III randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. In these trials, patients received QNASL^TM 320 mcg once-daily administered as two sprays in each nostril.

Allergic rhinitis (AR) is the most common allergic disease in the U.S., affecting between 10 to 30 percent of adults and adolescents. It affects more than one in five people, causing some to have symptoms year round (PAR) and others to experience symptoms during specific times of the year (SAR), such as spring or fall.

"Given the number of people living with allergic rhinitis who are still seeking adequate relief, the availability of a new dry nasal aerosol is very welcome news," said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA). "Seasonal and perennial allergies can have a significant impact on a person's quality of life and we commend Teva for providing patients with a great new option that expands access to quality care."

While intranasal corticosteroids are recommended as first-line therapy for AR, the only available options on the market prior to the approval of QNASL^TM (beclomethasone dipropionate) were aqueous formulations. Results from a 2010 survey entitled NASAL Allergy Survey Assessing Limitations (NASAL), showed that some nasal allergy patients reported dissatisfaction with their current allergy treatment. Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays.

"The approval of QNASL is a significant milestone for Teva Respiratory and represents our commitment to addressing the unmet needs of millions of Americans suffering from allergic rhinitis," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "We are committed to the development of new options for treatment of respiratory diseases that meet patients' needs."