FDA Approves Sublingual Tablet for Grass AllergiesLast Updated: April 02, 2014. Oralair has been approved by the U.S. Food and Drug Administration as the first sublingual treatment for certain grass allergies.
WEDNESDAY, April 2, 2014 (HealthDay News) -- Oralair has been approved by the U.S. Food and Drug Administration as the first sublingual treatment for certain grass allergies.
The tablet contains freeze-dried pollen extracts of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy. The once-daily tablet is placed under the tongue where it rapidly dissolves, the agency said in a news release.
Sanctioned for people aged 10 to 65, Oralair is designed to be started four months before the allergy season begins. The first dose should be given at a doctor's office, where the user can be observed for any serious reactions. After that, the product can be taken at home, the FDA said.
According to the FDA, some 30 million people in the United States and 500 million globally have been diagnosed with allergic rhinitis.
Oralair's safety and effectiveness were clinically evaluated in some 2,500 people. Those who took Oralair had up to 30 percent fewer allergy symptoms than those who took a placebo, the FDA said.
The product's label will include a boxed warning that people who are highly allergic to grass pollen may have a severe reaction, including life-threatening anaphylaxis. More common side effects reported were itchy ears and mouth, swelling of the mouth, and throat irritation.
Oralair is produced by the French firm Stallergenes S.A.
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