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April 3, 2014

FDA Approves Under-the-Tongue Hay Fever Pill

Little girl is blowing her nose

WebMD News from HealthDay

 By Robert Preidt

HealthDay Reporter

WEDNESDAY, April 2, 2014 (HealthDay News) — Just in time for the spring allergy season, the U.S. Food and Drug Administration on Wednesday approved a new under-the-tongue pill to treat hay fever caused by certain grass pollens.

Oralair is the first under-the-tongue allergen extract approved in the United States. The initial dose is taken in a doctor’s office so that the patient can be monitored for any harmful reactions, and follow-up doses are taken at home.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release.

“The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office,” she added.

Patients begin taking the once-a-day tablet four months before the start of the grass pollen season and continue taking it for the duration of the season, the FDA said in a news release.

Oralair contains a combination of freeze-dried extracts from the pollens of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.

The tablet was tested in studies in Europe and the United States that involved a total of about 2,500 people. Those who took Oralair had a 16 percent to 30 percent drop in symptoms and the need for allergy medications, according to the FDA.

The most common side effects reported by patients taking the tablets were ear, mouth and tongue itching, swelling of the mouth and throat irritation. Oralair will carry a special “black box” warning on its label about the possibility of severe and possibly life-threatening allergic reactions.

According to the FDA, over 30 million Americans suffer from what’s known as allergic rhinitis, often caused by a sensitivity to grass pollen. Symptoms include itchy or watery eyes, sneezing and nasal congestion.

Oralair is made by Stallergenes S.A. of France.


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