treatment available for grass-induced symptoms because the two would be cumulative,” says Dr. Harold Nelson, an allergist at National Jewish Health in Denver, and one of the studies’ lead investigators.
Is a Pill Market-Ready?
But don’t rip up your synthetic turf and start laying sod quite yet. The SLIT drugs aren’t perfect. About 70 percent of people who took Grazax complained of minor irritations, particularly for about the first week, Nelson says. Itchy tongue and mouth were common, sometimes with swelling, and some patients had itchy ears and throat. Cox views the Oralair side effects as minor, but 17 of 473 patients did withdraw the study because of an itchy mouth or unrelated health problems.
The even bigger issue right now, however, is getting your hands on either of the medications.
Merck has yet to apply to either the Food and Drug Administration or Health Canada for Grazax’s approval, and wouldn’t say when it plans to do so. Stallergenes also hasn’t applied to the FDA for Oralair to be approved, says Cox, and she doesn’t know when it will. “I think they’re afraid that they’ll be turned down,” says Cox. The FDA hasn’t approved a new drug containing allergens in nearly 20 years, and few companies have tried. In Canada, Paladin Labs has the license for Oralair, and applied in late May for Health Canada’s approval. Both Canadian and U.S. regulators take at least a year to make a decision once a pharmaceutical company applies for a drug’s approval.
Quicker Shots An Option
There’s one other quick-acting immunotherapy for grass that could also make an appearance soon. Needles are involved – but not nearly as many with current allergy shots.
Dr. Paul Keith, an allergist at McMaster University in Hamilton, Ontario, co-authored a study published this year on “ultrashort” immunotherapy for grass. The treatment requires four allergy shots, given within weeks, all before allergy season begins. Keith’s international study, which included Canadian patients, looked at the Allergy Therapeutics drug Pollinex Quattro.
During the peak of grass season, patients experienced a 13.4 percent improvement in symptoms and the need for medication over the placebo group. The improvement was even better when researchers looked only at the patients who did the best record-keeping of their symptoms, or the patients who had the most severe hay fever. That said, Allergy Therapeutics has yet to apply for U.S. or Canadian approval.
Although the ultrashort therapy is a big improvement over the dozens of needles required for existing allergy shots, it’s still not as convenient for consumers as taking a tablet in the comfort of home. “The big thing is you have to get an injection and be watched for 30 minutes for a reaction in the doctor’s office,” Keith says. “The tablets taken at home would clearly be more convenient.”
Convenient, but affordable? The price of Grazax varies among European countries. In a 2007 study of Grazax’s cost effectiveness, the tablets were selling in Germany for 2.95 Euros per tablet, about $4.15 U.S. Merck won’t speculate on the drug’s potential price in the United States.
Cox believes U.S. health insurers would be likely to cover the cost of the tablets, because of the drug’s net financial benefit to society. One European economic analysis found the economy saved money as long as Grazax stayed cheaper than six Euros, because it kept grass-allergic people at work, and out of doctors’ offices.
It all sounds so promising. But for now, patients who would like to try these treatments will have to continue to daydream about standing triumphantly in a freshly mowed field. Still, as Keith says: “It’s good to know there are good products on the way.”