The U.S. Food and Drug Administration (FDA) said Wednesday it has approved an under-the- tongue tablet to treat hay fever induced by certain grass pollens in people aged 10 through 65 years.

The once-daily pill, Oralair, manufactured by France's Stallergenes SA, is the first under-the-tongue allergen extract approved in the United States, the FDA said in a statement.

It contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy, and can provide a wide range of allergy coverage.

The first dose is taken at a doctor's office, where the patient can be observed for at least 30 minutes for potential adverse reactions and subsequent doses can be taken at home, the FDA said.

The agency said Oralair should be started four months before the expected onset of the grass pollen season and treatment continued throughout the season.

"While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said.

"The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider's office," Midthun said.

The FDA said the safety and effectiveness of Oralair were evaluated in studies in the United States and Europe, involving approximately 2,500 people.

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

The most common adverse reactions reported by patients were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation.

According to the FDA, hay fever affects 30 million people in the United States and more than 500 million persons worldwide. Affected people may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes. Endite

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