Ragwitek, a drug designed to combat hay fever, has been approved by the Food and Drug Administration (FDA). Pollen allergies are common among the world, and this drug is meant for treatments of symptoms in adults aged 18 and over.
Ragwitek is a brand name, short for (Short Ragweed Pollen Allergen Extract).
Designed by pharmaceutical giant Merck, the pill is held under the tongue of the person taking the medicine. There, it quickly dissolves, delivering the desired dose to the patient. Users of the medicine are advised to take one tablet a day.
The new treatment contains an extract from the short ragweed, Ambrosia artemisiifolia. The drug should be started 12 weeks after the beginning of ragweed season, which is late summer to early fall in most of the United States.
A doctor should administer the first dose, in order to watch for adverse reactions. The FDA recommends doctors prescribe epinephrine, which can be injected to treat allergic reactions. After the first pill, regular does may be administered at home, according to the agency.
Ragwitek was approved by the FDA just days after the agency also okays another pollen allergy drug from Merck, called Grastek.
"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said.
The study testing safety and effectiveness of Ragwitek involved 1,700 adult subjects. Of these, 760 were used in tests to determine the efficacy of the drug. During the research, some volunteers were provided with Ragwitek, while others were given a placebo. Throughout the allergy season, participants reported symptoms and other medicines needed to combat the effects of their condition. Subjects quantified their experiences when their nose was stuffed, itchy or runny, and when their eyes were itchy or watery. Researchers found a 26 percent drop in both symptoms and use of other drugs for patients using the new allergy treatment.
Side effects of the new medicine include itching of the ears and mouth, as well as throat irritation. Patients who have severe allergic reactions to A. artemisiifolia are being advised to steer clear of the medicine. A warning label will warn users of that possibly-dangerous combination. That form of pollen is one of the most common of all seasonal allergens.
About 4.5 million Americans between the ages of 20 and 64 suffer from moderate to severe allergies to the pollen that causes hay fever.
