The FDA has approved a new injectable drug that’s expected to ease the pain of debilitating headache clusters.
You wake up in the middle of the night with excruciating pain behind your right eye.
Tears are streaming down your face, your nose is running, your eyelid is drooping.
You pace the floor, restless and agitated.
Eventually the pain stops. But it comes back again, as many as eight times within a single day.
And that cycle of attacks can continue for several weeks or months.
That’s the classic description of what happens to people who experience episodic cluster headaches.
Now for the first time, a new drug specifically targeting those headaches has gotten the green light.
Last week, the Food and Drug Administration (FDA) approvedTrusted Source the use of Emgality to treat this often debilitating condition.
“Emgality is the first time we have a treatment for cluster headaches based on what we know about what happens in the brain during a cluster headache attack,” Dr. Rashmi B. Halker Singh, a headache neurologist at the Arizona campus of the Mayo Clinic, told Healthline.
“It’s designed specifically for headache pain and it’s really exciting,” she said.
Pharmaceutical Company Eli Lilly makes the drug.
In a statement, the company told Healthline that Emgality works by blocking a protein called CGRP or calcitonin gene-related peptide.
CGRP is involved in the transmission of pain in the brain and nervous system. Researchers found that CGRP levels increase when patients have migraine or cluster headaches.
The FDA first approved Emgality last September to prevent migraine. Aimovig from Novartis and Ajovy from Teva are two other drugs in the new category of CGRP inhibitors the agency approved last fall to treat migraine headaches.
The American Migraine Foundation has described them as groundbreaking new treatments.
Eli Lilly continued researching whether Emgality would work for episodic cluster headaches.
In its news release, the FDA said Emgality was tested in a clinical trial involving 106 patients over a three-week period.
Researchers measured the average number of cluster headaches per week. They found that people taking Emgality had 8.7 fewer headache attacks versus 5.2 fewer attacks for people on a placebo drug.
Singh said she hasn’t yet used Emgality to treat her patients with episodic cluster headaches, but she has prescribed it for people with migraine headaches along with the other CGRP inhibitors.
“I’ve been using it quite a bit for my patients who have migraine. About half see about a 50 percent reduction in headache frequency, a third see about a 75 percent reduction in the frequency,” she said.
“It’s been really life-changing for so many of my patients. Some had tried numerous other medications and did not find those drugs to be helpful,” she added.
Singh said there have been few options to treat the episodic cluster headaches until now.
“Our first line of treatment up to this point has been a drug called verapamil, a blood pressure medication that requires close monitoring,” she explained. “We were using things designed to treat other conditions that we kind of pulled into the headache world.”
Emgality is injected by the person using it.
Eli Lilly officials told Healthline the dosage is different for migraine and episodic cluster headaches.
People living with migraine inject themselves once a month to prevent their headaches.
For episodic cluster headaches, the recommended dosage is three consecutive injections when the cluster attack begins. People then inject themselves monthly until that cycle ends.
The company says the cost of Emgality taken monthly for migraine is $6,900 a year.
It could cost more or less to treat the episodic cluster headaches, depending on the number of doses needed.
“I can’t overemphasize how important this is for patients who have cluster headaches” Singh said. “People describe it as a searing pain, kind of like a hot poker through their eye.”
Singh said the future of treatments looks promising.
“Last year and this year, we’ve come up with a lot of improvements for patients that have cluster headaches and migraine,” Singh said. “This is only the beginning. I’m excited for all the other treatments coming down the pipeline.”