The FDA has approved Oralair, the first under-the-tongue allergy medication approved in the US for the treatment of hay fever, with or without eye inflammation for sufferers 10-65 years old.
While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,”states Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
Grass pollen allergies affect more than 30 million people in the United States and more than 500 million people troughout the rest of the world. Sufferers offer experience repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes.
Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy. is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season.
The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, as well as 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. However, the drug does come with a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur.
To learn more health care professionals and consumers can contact the FDA at 888-INFO-FDA, as well as OCOD@fda.hhs.gov