FDA Approves First 'Dry' Nasal Aerosol for Allergic Rhinitis

Mark Crane

Disclosures

March 26, 2012

March 26, 2012 — Just in time for the spring allergy season, the US Food and Drug Administration (FDA) has approved a new nasal aerosol corticosteroid that treats seasonal and year-round nasal allergy symptoms that affect as many as 60 million Americans.

QNASL Nasal Aerosol (beclomethasone dipropionate) is a new, "dry" nasal aerosol corticosteroid developed by Teva Pharmaceuticals, based in Jerusalem, Israel.

The product is expected to be available by prescription in April and will be the first marketed nonaqueous 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-propelled nonaqueous aerosol and offers a built-in dose counter.

"There are some patients with allergic rhinitis [AR] who report dissatisfaction with the currently available therapies," Gary N. Gross, MD, practicing allergist, cofounder of the Dallas Asthma and Allergy Center in Texas, and an investigator involved in the QNASL clinical trials, said in a company news release. "The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery."

"Many patients have an aversion to a wet nasal spray because of the perception that it runs out and is therefore ineffective," he told Medscape Medical News. "That, plus the postnasal drainage causes them to be less likely to continue its use. This new formulation provides another tool that more patients may be willing to use."

QNASL Nasal Aerosol (beclomethasone dipropionate)

Although intranasal corticosteroids are recommended as first-line therapy for AR, the only available options on the market before the approval of QNASL were aqueous formulations. Results from the NASAL Allergy Survey Assessing Limitations (NASAL) survey in 2010 showed that 1 in 5 patients with nasal allergies reported dissatisfaction with their current allergy treatment.

Physicians said that some of their patients with AR have asked them to change their intranasal steroid spray because they were dissatisfied with it, either because it was ineffective at treating symptoms or because of uncomfortable adverse effects.

One third of allergy patients who have used a nasal steroid spray in the last year named "dripping down the throat" as a moderately or extremely bothersome adverse effect, along with nose bleeds, the study reports.

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

AR is the most common allergic disease in the United States, affecting between 10% and 30% of adults and adolescents. It affects more than 1 in 5 people, causing some to have symptoms year round and others to experience symptoms during specific times of the year, 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," Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America, said in the company release.

"Our own surveys show that allergy patients often use more than one treatment, often over-the-counter products. So they may use a nasal spray, eye drops, and a pill. They are willing to experiment on new options to seek relief. Some aren't comfortable with the wet sensation, and this new product may bring in a new group of patients," Tringale told Medscape Medical News.

AR is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. For many patients with AR, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom.

The prevalence of AR has increased during the past 3 decades, and it 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 per year are attributed to AR, according to the NASAL study. In addition, the presence of comorbidities such as asthma and sinusitis further increase AR-related treatment costs.

One in 5 adults with nasal allergies feels that their health limits them in doing well at work, according to the NASAL study. Sixty percent of adults with nasal allergies reported they felt miserable, 67% reported feeling irritable, and 85% said they felt tired. These patients also reported difficulty in sleeping.

The most common adverse effects with QNASL Nasal Aerosol are nasal discomfort, nosebleeds, and headache, according to the Teva statement.

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