First SL Allergy Immunotherapy Tablet Approved
Greer Laboratories announced that the FDA has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in patients aged 10–65 years, as confirmed by a positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the 5 grass species contained in the product.
Oralair contains an allergen extract that is intended to increase the immunological tolerance towards grass pollens, and thus reducing the allergic symptoms.
The approval was based on the safety, efficacy, and tolerability results from double-blind, placebo-controlled clinical trials that included over 2,500 patients in the U.S. and Europe. Positive results showed that pre-seasonal and co-seasonal treatment with grass allergy immunotherapy reduced patients' allergy symptoms and their need for symptom-relieving medication. Traditional allergy immunotherapy has been given as a series of subcutaneous injections in the specialist's office.
Oralair will be available in 100 IR and 300 IR sublingual tablets in blister packs containing 1x3 tablets (100 IR) and 1x28 tablets (300 IR).
For more information call (800) 378-3906 or visit GreerLabs.com.