Oralair was approved April 1 by the Food and Drug Administration for the treatment of allergic rhinitis; it is the first sublingual allergen extract approved for use in the United States.
Oralair is indicated to treat allergic rhinitis with or without eye inflammation that is induced by certain grass pollens in people aged 10-65 years. The company had proposed that the treatment be approved for patients aged 5 years and older.
The treatment contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy.
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Millions of Americans suffer from grass allergy symptoms every year, said Dr. Linda Cox.
Once-daily Oralair is started 4 months prior to the grass-pollen season and continued throughout the season. The first dose is delivered in the doctor’s office, and the remaining doses can be self-administered at home. Manufacturer Greer Laboratories claims that Oralair may reduce grass allergy symptoms for patients within the first allergy season it is taken.
Treatment with a sublingual tablet would open up the treatment options for the approximately 30 million Americans who suffer from allergic rhinitis every year, said Dr. Linda Cox, immediate past president of the American Academy of Allergy Asthma and Immunology and a practicing allergist in Ft. Lauderdale, Fla.
She said that she sees it as a game changer for the treatment of allergic rhinitis.
"What sublingual immunotherapy offers is home treatment and easier access to care because its safety profile is so good," Dr. Cox said in an interview. "That could potentially open up this treatment for the 90% or so of patients who are not receiving anything and are just treating the symptoms."
She added that Oralair treats the underlying causes of allergic rhinitis, not just the symptoms caused by the disease. "It will bring a group of people who are just suffering through their [allergy] seasons and are getting suboptimal control with various products and give them the potential to just knock out their disease," she added.
Approval of Oralair was based on double-blind, placebo-controlled trials in the United States and Europe that enrolled more than 2,500 adults and children. To assess the treatment’s effectiveness, patients reported their symptoms and additional medications needed to cope with their allergy symptoms. During treatment for one grass-pollen season, patients taking Oralair saw a 16%-30% reduction in symptoms and the need for medications, compared with those who received a placebo.
The trials demonstrated that treatment with Oralair before and during allergy season reduced patients’ allergy symptoms and their need for symptom-relieving medication.
The most common adverse events for Oralair, reported in less than 5% of patients, were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain, Greer Laboratories said in an April 1 statement.
Oralair was first approved in Europe in 2008, and is currently approved in 31 countries.