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FDA Approves First Sublingual Allergen Extract for Grass Pollen Allergies

Treatment indicated for patients 10 through 65 years of age

The FDA has approved Oralair (Stallergenes S.A.) to treat allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in people aged 10 through 65 years. It is the first sublingual allergen extract to be approved in the U.S.

Allergic rhinitis with or without conjunctivitis is a chronic disease that affects approximately 30 million people in the U.S. and more than 500 million persons worldwide. The disease is often caused by sensitivity to grass pollen. Affected people may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes.

Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Treatment is started 4 months before the start of the grass pollen season and is continued throughout the season. The first dose is administered at the health care provider’s office, where the patient is observed for at least 30 minutes for potential adverse reactions. Afterwards, Oralair can be taken at home.

The treatment contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy.

The safety and effectiveness of Oralair were evaluated in studies involving approximately 2,500 people in the U.S. and Europe. Some subjects received Oralair, and others received placebo. The subjects reported their symptoms and additional medications needed to get through the allergy season.

During treatment for one grass pollen season, subjects taking Oralair experienced a 16% to 30% reduction in symptoms and in the need for medications compared with those who received placebo.

The product’s prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Oralair also has a medication guide for distribution to patients.

The most common adverse reactions reported by adults were itching in the ears and mouth, itching of the tongue, swelling of the mouth, and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.

Source: FDA; April 2, 2014.

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