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Under-the-Tongue Pills for Grass Allergy

From the Summer 2011 edition of Allergic Living magazine.

Spring and early summer present a constant dilemma for people allergic to grass [1]. It’s a choice between dodging pollen behind tightly sealed windows, or engaging in a battle with the blades, hoping antihistamines, nasal sprays and eye drops will keep the worst of the symptoms at bay.

A lot of us are making this daily choice between nose-streaming suffering and indoor boredom. It’s estimated that about 26 percent of North Americans are sensitized to either Timothy or rye grasses, and 18 percent to Bermuda grass, often used on golf courses.

Allergy shots have long been an option for those who can’t bear all the congestion and mucus any longer, but they require a serious commitment to needles and doctor’s visits, week after week, allergy season after allergy season, for several years.

For the moment, those shots are the only game in town. But that may be about to change. Needles may soon give way to small tablets, placed under the tongue and allowed to dissolve for about a minute. And, impatient people, rejoice: the tablets – called sublingual immunotherapy or SLIT – may significantly improve hay fever symptoms within a month. The best news? Two SLIT pills have recently completed the final phase of testing in the U.S. and their makers getting ready to apply for regulatory approval.

Dr. Linda Cox, a Fort Lauderdale, Florida allergist who organized a large study for one of the drugs, has spent years looking at the limitations and safety of immunotherapy for environmental allergens like grasses. She points to European research that followed patients who took grass SLIT tablets to note how life-changing the drug can be. Years after patients stopped taking the tablets, the protective effects still lingered. “No [other] medication does that,” Cox says. “You can’t take a drug for a season and expect the next season it will have [still] fixed your problem.”

With pollen seasons [2] becoming longer in many areas, such therapies could be all the more important, as allergy sufferers are faced with the threat of even longer stretches of congested misery.

The Contenders

One of the SLIT drugs is called Oralair in Europe, and is produced by the French company Stallergenes. It contains extracts from five northern grasses, including orchard grass, Kentucky bluegrass, perennial ryegrass, sweet vernalgrass and Timothy grass, most of which are found in nearly every North American state and province. Like other immunotherapies, the drug works by repeatedly exposing the body to tiny amounts of allergen over several months, which helps to desensitize the allergy sufferer just in time for a spring blast of pollen.

In a U.S. study of Oralair, 473 grass-allergic adults in several northern and central states got either the drug or a placebo for six months. Researchers found a 28 percent improvement in allergy symptoms and medication use compared to the group getting the sugar pills. Oralair was particularly good at relieving itchy and watery eyes, and patients also said they slept better.

The other tablet that could soon be on North Americans’ relief radar is known as Grazax in Europe (where SLIT tablets have been on the market since 2006). Danish company ALK makes the tablet, but drug-manufacturer Merck is spearheading the American research and push for approval. Unlike Oralair, Grazax focuses its immunological attack on just one pollen: Timothy grass, which is found everywhere in North America except Nunavut and Puerto Rico.

In one U.S. study of Grazax, adults showed about a 20 percent improvement in symptoms. In another, children’s allergy symptoms improved by 26 percent. “If somebody takes Grazax, and uses nasal steroids and antihistamines on top of it, then this would be by far the most effective 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.”


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