Oralair is now the first sublingual (under the tongue) allergen extract approved in the United States after receiving FDA clearance to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years.
Oralair, a once-daily tablet that rapidly dissolves after being placed under the tongue, is started four months before the start of the grass pollen season and continued throughout the season, according to the FDA.
Oralair, which is manufactured by Stallergenes SA of Antony, France, contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.
The FDA emphasized that the first dose must be taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions. Subsequent doses of Oralair can be taken at home.
Allergic rhinitis with or without conjunctivitis affect approximately 30 million people in the United States and more than 500 million persons worldwide, according to the FDA.
These diseases are 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.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots.”
Based on studies in the US and Europe involving approximately 2,500 people, patients taking Oralair experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo, according to the FDA announcement.
More information on the drug is available on the FDA website.