The FDA has approved the first sublingual allergen extract to treat
rhinitis — with or without conjunctivitis — caused by grass
pollens. The once-daily tablet (Oralair) is indicated for patients
aged 10 to 65 years.
The drug contains a mix of five grass pollens: Kentucky Blue Grass,
Orchard, Perennial Rye, Sweet Vernal, and Timothy. In studies among
some 2500 patients, those taking Oralair had a 16% to 30% reduction in
symptoms compared with those on placebo.
The first dose should be administered in a clinician’s office (before
the start of the grass pollen season) so that the patient can be
observed for adverse reactions. The prescribing information includes a
boxed warning about potentially life-threatening allergic reactions
(e.g., anaphylaxis). The most common side effects include itching and
swelling in the mouth, and throat irritation.
FDA news release