A Stallergenes machine acts as a pollen vacuum cleaner. The pollen is used in the drug company’s immunotheraphy treatments.
“One drop under the tongue every morning, and that’s it,” said Ms. Hickey, 65, who lives in Beaver Falls, Pa. She is free of symptoms and sinus infections from her allergies to ragweed and tree pollens, she said.
Injections have been used to treat allergies from inhaled substances — often known as hay fever — for 100 years, and the basic formula has changed little. But an alternative is now emerging — liquids or tablets placed under the tongue.
Both Merck and Stallergenes, a French company, are seeking marketing approval for tablets to treat grass pollen allergies. An advisory committee to the Food and Drug Administration will discuss the drugs next week.
The drugs are already available in Europe. If they are approved in the United States, they could make this type of therapy more broadly available, by allowing people to treat themselves at home rather than going for frequent shots. Children, who tend not to like needles, might also find such treatment more acceptable. Approval would also deliver some extra credibility to this type of therapy, which aims to fundamentally alter the immune system.
“It’s hugely important,” said Dr. Linda S. Cox, president of the American Academy of Allergy, Asthma and Immunology.
But there are drawbacks. The shots can be tailored to match the patient’s allergies while the liquid drops and tablets are standardized.
An estimated 30 million to 60 million Americans, including up to 40 percent of children and 10 to 30 percent of adults, suffer nasal congestion, runny nose, sneezing, itchy eyes or other symptoms from allergies to something they inhale.
The typical treatments are antihistamines or nasal steroids. But those drugs merely alleviate symptoms.
Immunotherapy, as allergy shots and under-the-tongue treatments are called, involves giving controlled doses of the allergen to teach the immune system to tolerate it. That can lead to longer-lasting relief.
Some studies have shown that three years of immunotherapy provides substantial relief for two years after treatment is stopped, in some cases for longer. Some studies also suggest that immunotherapy can reduce the risk of developing asthma.
But only a small percentage of people with respiratory allergies get the shots.
One reason is that people have to visit the doctor for shots at frequencies ranging from twice a week to once a month for several years. Another is that immunotherapy, while now broadly accepted as studies have accumulated, has had its doubters.
“Allergists always had a bad rap,” said Dr. David P. Skoner, chief of allergy, asthma and immunology at Allegheny Health Network in Pittsburgh. “We were called quacks and shot doctors. The reason was the science wasn’t there.”
The allergen extracts used for the shots are approved by the F.D.A. on the basis of their safety, purity and potency. But because immunotherapy has been around for so long, extracts generally do not go through clinical trials to prove they can actually help tame allergies.
Merck and Stallergenes, by contrast, have done controlled clinical trials and are seeking approval on the same basis as any other drug. That could enhance the credibility of the treatments.
In Merck’s biggest trial, involving 1,500 adults and children who are allergic to Timothy grass, those who took the tablets had a 20 percent reduction in symptoms during one allergy season compared with those who received a placebo. They also used antihistamines or other symptom-relieving drugs less often. Stallergenes’ results were in the same ballpark.
Still, not all allergists will welcome the tablets. That is because they make money giving shots, while the tablets would be prescribed like other pills.
“One drop under the tongue every morning, and that’s it,” said Ms. Hickey, 65, who lives in Beaver Falls, Pa. She is free of symptoms and sinus infections from her allergies to ragweed and tree pollens, she said.
Injections have been used to treat allergies from inhaled substances — often known as hay fever — for 100 years, and the basic formula has changed little. But an alternative is now emerging — liquids or tablets placed under the tongue.
Both Merck and Stallergenes, a French company, are seeking marketing approval for tablets to treat grass pollen allergies. An advisory committee to the Food and Drug Administration will discuss the drugs next week.
The drugs are already available in Europe. If they are approved in the United States, they could make this type of therapy more broadly available, by allowing people to treat themselves at home rather than going for frequent shots. Children, who tend not to like needles, might also find such treatment more acceptable. Approval would also deliver some extra credibility to this type of therapy, which aims to fundamentally alter the immune system.
“It’s hugely important,” said Dr. Linda S. Cox, president of the American Academy of Allergy, Asthma and Immunology.
But there are drawbacks. The shots can be tailored to match the patient’s allergies while the liquid drops and tablets are standardized.
An estimated 30 million to 60 million Americans, including up to 40 percent of children and 10 to 30 percent of adults, suffer nasal congestion, runny nose, sneezing, itchy eyes or other symptoms from allergies to something they inhale.
The typical treatments are antihistamines or nasal steroids. But those drugs merely alleviate symptoms.
Immunotherapy, as allergy shots and under-the-tongue treatments are called, involves giving controlled doses of the allergen to teach the immune system to tolerate it. That can lead to longer-lasting relief.
Some studies have shown that three years of immunotherapy provides substantial relief for two years after treatment is stopped, in some cases for longer. Some studies also suggest that immunotherapy can reduce the risk of developing asthma.
But only a small percentage of people with respiratory allergies get the shots.
One reason is that people have to visit the doctor for shots at frequencies ranging from twice a week to once a month for several years. Another is that immunotherapy, while now broadly accepted as studies have accumulated, has had its doubters.
“Allergists always had a bad rap,” said Dr. David P. Skoner, chief of allergy, asthma and immunology at Allegheny Health Network in Pittsburgh. “We were called quacks and shot doctors. The reason was the science wasn’t there.”
The allergen extracts used for the shots are approved by the F.D.A. on the basis of their safety, purity and potency. But because immunotherapy has been around for so long, extracts generally do not go through clinical trials to prove they can actually help tame allergies.
Merck and Stallergenes, by contrast, have done controlled clinical trials and are seeking approval on the same basis as any other drug. That could enhance the credibility of the treatments.
In Merck’s biggest trial, involving 1,500 adults and children who are allergic to Timothy grass, those who took the tablets had a 20 percent reduction in symptoms during one allergy season compared with those who received a placebo. They also used antihistamines or other symptom-relieving drugs less often. Stallergenes’ results were in the same ballpark.
Still, not all allergists will welcome the tablets. That is because they make money giving shots, while the tablets would be prescribed like other pills.
