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A million Americans with cluster headaches may finally get relief with the approval of the first drug specifically designed to treat the rare but devastating disease that primarily affects younger men.
Patients often have to take medications that cause significant side effects such as swelling of the legs. But on Tuesday, the Food and Drug Administration approved a new treatment – a single monthly injection, Emgality, made by Eli Lilly.
In a recent clinical trial, it was shown that the drug significantly reduced the number of cluster headache attacks – from an average of eight headaches to five a week – with little effect secondary.
"Emgality provides patients with the first FDA-approved drug that reduces the frequency of episodic headache attacks, an extremely painful and often debilitating condition," said Dr. Eric Bastings, deputy director of the Division of Neurological Products at the Center for Drug from the FDA. Evaluation and research, said in a press release.
Negative skills belong to a new class of drugs called CGRP inhibitors, used to prevent or reduce the frequency of migraines. It is one of three drugs of this class for migraines that were put on the market last year.
"The study was not very long, it only lasted three weeks, but these drugs are interesting and have a lot of potential," said Dr. Alan Shepard, neurologist and headache specialist at Northwestern Memorial Hospital. "It's something we'll try more in the future."
"Cluster headaches are 90% more common in men between the ages of 30 and 40," Shepard said. But despite the small number of people affected by this disease, doctors are very excited about the approval of the drug.
"The drugs seem to be safe and effective and most neurologists will probably start using them for different types of headaches," he added.
According to the American Migraine Foundation, cluster headaches, which are a subtype of migraines, most commonly occur between the ages of 20 and 40 and can affect up to 1 million people in the United States. However, no exact number has been determined by the researchers.
Like migraines, they cause intense pain and an inability to function a lot when they hit. Unlike migraines, which tend to be more common in women, the disease is slightly more common in men.
Less than 1% of people suffer from cluster headaches. Most patients have a form called episodic cluster headaches, which come and go, by periods or cycles, says the American Migraine Foundation. People who suffer from it can spend months without a crisis and then have several sudden headaches – each lasting anywhere from 15 minutes to three hours – in one day or several days. They usually occur during the night, waking people up.
The disease often remains undiagnosed as it is associated with symptoms common to other diseases, such as bloodshot eyes, excessive tearing, droopy eyelids and nasal congestion.
The drugs currently used to treat cluster headaches include drugs used to treat heart and psychiatric problems. Often, these medications are prescribed in high doses and cause side effects, such as swelling of the legs, said Dr. Dario Zagar, president of Connecticut's Southern Associate Neurologists.
Treatment for self-injected migraine is a solution that needs to be administered once a month. Patients will receive a monthly dose of 300 milligrams, compared to a dose of 120 mg per month for the prevention of migraine headaches. The price of the drug will cost about $ 7,000 a year, but it may vary depending on the duration of the treatment.
"An injection once a month is a good thing, especially for young patients who are currently taking the drugs we use and who potentially have a lot of side effects," Zagar said.
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