First drug to reduce ‘suicide headaches’ gets FDA approval


The first drug to treat debilitating cluster headaches was approved this week by the US Food and Drug Administration (FDA). 

Sometimes described as ‘suicide headaches,’ cluster headaches are thought to be the most painful kind, leaving sufferers with short, intense bouts of head pain that last around 15 minutes and repeat over the course of a day. 

These recurrent headaches may happen over and over for weeks or months at a time, often at the same time of day or year, and often go untreated or mistreated.

Tuesday, the FDA approved Emgality, an injectable drug to treat the headaches, and the first shown to reduce the frequency of cluster headaches. 

There are between 200,000 and one million Americans who periodically pace, rock or even bang their heads against walls or tables in desperate attempts to distract themselves from the searing pain of cluster headaches. 

Cluster headaches typically strike between one and eight times over the course of a day. 

Attacks tend to repeat for weeks or months at time, and most patients get ‘remission’ periods during which they are headache-free for up to years at a time, a minority suffer chronic cluster headaches, and get no extended relief. 

Cluster headaches often happen seasonally or around the same time of day, so they get dismissed as a byproduct of seasonal allergies. 

Alternatively, because clinicians are so much more familiar with migraines, doctors may conflate the two kinds of headaches. 

But cluster headaches are distinct from migraines, too – both in their symptoms and neurology. 

And that means that proper treatment for cluster headaches should be different from treatment for migraines. 

Migraines tend to have environmental or circumstantial triggers and while more women get migraines, cluster headaches primarily strike young men. 

Cluster headaches, although they come on at repetitive times and are mistakenly linked to stress, don’t have triggers. 

They come on fast, often with a burning sensation focused on one side of the head, and are thought to be caused by neurotransmitter imbalances, particularly related to dopamine. 

Their cyclical natures, scientists suspect is related to the hypothalamus and its role in the biological clock.

Onset of cluster headaches may follow a mild burning sensation, usually on one side of the head. 

Once the headache begins in earnest, people may look visibly in pain, and have one or two drooping eyelids.  

Until now a handful of drugs were available to shorten each headache episode, but they didn’t work to shorten the duration of a cycle, or cluster of headaches. 

And the some of the most effective treatments involved an injection to the back of the head that has to be given by a doctor or nurse. 

The new drug, Emgality, is still an injection, but it can be self-administered at home. 

It appears to cut down the number of headaches a patient develops in a series – albeit modestly. 

Clinical trials of Emgality found that the drug reduced the frequency of headache attacks by about 8.7 a week. 

The placebo group had 5.2 fewer headaches than they had without medication. 

Still, it could offer nope to those suffering notoriously stubborn cluster headaches. 

Some patients reported hypersensitivity – allergy-like immune responses – to the shot. 

Still, for some cluster headaches, the drug is a first step in the right direction. 

‘Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,’ said Dr Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

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