The U.S. Food and Drug Administration on Wednesday approved the first under-the-tongue pill that could replace some allergy shots, HealthDay reported.
Oralair, from the French company Stallergenes, is used to treat hay fever caused by certain grass pollens. The initial dose of the medicine will be taken in the doctor's office so "that the patient can be monitored for any harmful reactions," HealthDay reported.
Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue.
"While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen," Dr. Karen Midthun, director of theFDA's Center for Biologics Evaluation and Research, said in an agency news release. "The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider's office."
Like shots, the pill takes several months to start working. The under-the-tongue pill will not reach grass-allergy sufferers in time to ward off early summer symptoms this year, USA Today reported.
The tablet contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy, according to FDA officials.
The safety and effectiveness of the under-the-tongue tablet was evaluated in studies in the United States and Europe, involving approximately 2,500 people. Some patients received Oralair; others received an inactive substitute (placebo). To assess the effectiveness, patients reported their symptoms and additional medications needed to get through the allergy season.
During treatment for one grass pollen season, patients taking Oralair experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo.
The most common side effects reported by patients taking the tablets were ear, mouth and tongue itching, swelling of the mouth and throat irritation.
FDA officials said people should start using the tablet four months before the start of the grass pollen season and continued throughout the season.
