The first pill that could replace allergy shots for some people has been approved by the Food and Drug Administration.
Oralair, from the French company Stallergenes, only works against certain grass pollens and, like shots, takes several months to start working. So it won't help people allergic to other things or reach grass-allergy sufferers in time to ward off early summer symptoms this year.
But it does signal a shift in immunotherapy – the practice of exposing allergy sufferers to small amounts of the substances that trigger symptoms in order to decrease sensitivity and reduce symptoms when sufferers encounter the real thing.
Up to now, that has usually meant returning to allergists' offices many times over months or years to get shots. Some allergists also offer custom-made drops that can be placed under the tongue, but those have never been approved by the FDA.
Immunotherapy in take-home pill form "is a significant advance and certainly one of the few brand new products we've had in quite a long time," says James Li, chairman of the division of allergy and immunology at Mayo Clinic in Rochester, Minn., and president of the American Academy of Allergy, Asthma & Immunology.
Patients will place the new grass pollen pills under their tongues – the first time in a doctor's office, just in case of severe allergic reactions. After that, the pills will be taken once a day at home. The pills can cause some side effects: In studies, one third of patients developed itchy mouths and some reported throat irritation.
FDA says the pills reduced symptoms and the need for allergy medication by 16% to 30% in studies.
That's somewhat lower than the effectiveness of shots in studies, but the two kinds of therapies have not been compared head to head, Li says.
One big drawback of the new pill is that it treats just one kind of allergy, says Stanley Fineman, an Atlanta allergist and past president of the American College of Allergy, Asthma and Immunology.
"Most patients with allergies that we see here are allergic to grass pollens, tree pollens, ragweed and environmental allergens like dust mite and animal dander," he says. A typical allergy shot contains all those extracts, he says.
But he says the tablets will give some patients a welcome new option. "We are going to have to get some hands-on experience before we say where it's going."
The Stallergenes pill works against five types of grass pollen common in the United States: Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass.
It's been approved for people ages 10 to 65. The company says the pills, which will be available in May, should be started four months before grass allergy season and continued through the season — a time period that differs by geographic region. It did not immediately release a price.
Additional immunotherapy pills are in the pipeline. FDA is expected to approve a second grass pollen pill, from Merck. That pill works against just one variety, Timothy grass. FDA also is reviewing a ragweed pill from Merck and the company has a dust mite pill in studies.
Not everyone with allergies needs immunotherapy. People with milder, easier-to-control symptoms can try limiting their exposure to the substances that bother them and many people can control runny noses, itchy eyes and sneezes with antihistamines and steroid nasal sprays, Li says.