FDA approves first pill for pollen allergies
As the spring allergy season gets underway, a new pill to treat grass pollen allergies was approved this week by the US Food and Drug Administration. Oralair -- a once-daily tablet that rapidly dissolves after it is placed under the tongue -- treats sneezing, congestion, running nose, and itchy, watery eyes caused by hay fever.
It’s the first treatment made with an allergen extract that’s not a shot approved for use in the United States for allergy sufferers ages 10 through 65.
The first dose needs to be given in a doctor’s office to determine if there are any allergic reactions, according to the FDA. People can take subsequent doses at home.
“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 the FDA’s Center for Biologics Evaluation and Research said in a statement. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office.”
Like allergy shots, Oralair should be started four months before the start of the grass pollen season -- which usually hits during the late spring -- and continued throughout the allergy season.
The FDA reviewed clinical trials involving about 2,500 people found that those who were treated with Oralair had a 16 to 30 percent reduction in their allergy symptoms compared to those given a placebo. The manufacturer didn’t compare, though, whether Oralair was as effective as allergy shots.
The drug contains warning about severe allergic reactions — such as life-threatening anaphylaxis — that can occur from the product. The most common side effects in adults were itching in the ears and mouth and on the tongue, as well as swelling of the mouth and throat irritation, according to the FDA. Children were most likely to experience itching and swelling in the mouth and throat irritation.