FDA approves 'dry' nasal aerosol to treat allergy symptoms

FDA has approved beclomethasone dipropionate (QNASL Nasal Aerosol, Teva Pharmaceutical Industries), a “dry” nasal aerosol corticosteroid that treats year-round and seasonal nasal allergy symptoms in people aged 12 years and older.

QNASL is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly and offers a built-in dose counter, according to Teva’s news release.

The aerosol is expected to be available 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.

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

The approval of QNASL 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 aged 12 years and older.

The safety and efficacy of QNASL Nasal Aerosol was demonstrated in 4, phase 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. In these trials, patients received QNASL 320 μg once-daily administered as 2 sprays in each nostril.

Allergic rhinitis (AR) is the most common allergic disease in the United States, affecting between 10% to 30% of adults and adolescents. It affects more than 1 in 5 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. It is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion.

Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimated $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences, and 3.5 million lost work days are attributed to AR per year. In addition, the presence of comorbidities such as asthma and sinusitis further increase AR-related treatment costs.

Intranasal corticosteroids are recommended as first-line therapy for AR, but the only available options on the market before the approval of QNASL were aqueous formulations.

Results from a 2010 survey called 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.

Full prescribing information is available on the company’s