FDA Approves Groundbreaking Rescue Treatment for Cluster Seizures

The nasal spray is the first medication approved in more than 20 years to treat this symptom of epilepsy.

Seizures can be scary, and they can strike at any time, sometimes without warning. But for people with epilepsy, seizures are also a way of life. And for some, one seizure can spiral into another for a prolonged period, called cluster seizures. Left untreated, these episodes can cause neurological complications and brain damage.

But there’s good news: The Food and Drug Administration has approved Nayzilam (midazolam), a cluster seizure-fighting nasal spray—the first medication of its kind approved in more than 20 years.

Hae Won Shin, MD, an associate professor at UNC School of Medicine and co-investigator of the Nayzilam clinical trial at UNC, explains why the spray’s approval is so important.

Why is Nayzilam’s approval groundbreaking?

Oftentimes, seizures happen in unpredictable ways. Usually people say seizures come at the most inconvenient place and time, and often they last more than a few minutes. When that happens, we try to provide rescue medicine, or immediate, short-term treatment.

Until now, the only FDA-approved rescue medication was diazepam, which is administered through the rectum. If you have a small baby, it’s not too difficult to administer medicine anally. But if you think about school-aged children or adults having seizures in public places, it’s not that easy to get them in the fetal position and administer the medication. There’s a social aspect to it, too. Seizures can be embarrassing. And not only is it just about having a seizure in public, but on top of that, to use the medication, they also would have to get partially naked, which can make the experience more humiliating. So even though there was a rescue medicine available, a lot of times it wasn’t widely used among teenage and adult patients.

We’ve tried using the medication in an alternative way to get around those factors. For example, we thought maybe if we put the medication in the cheek during a seizure, it might also be effective. But then there’s a risk that someone’s face muscles might tense up and tighten, and we wouldn’t be able to get the medicine to them safely.

Another option was to introduce midazolam as an intranasal medication. It’s a really novel concept, and it works. Nayzilam can be administered by anybody and easily used in public. It also makes it easier for caregivers, who will no longer have to fight with patients to get them undressed to administer medication. That’s why I’m excited about this medication getting approved.

What are cluster seizures, and why is it important to administer rescue medication?

Seizures tend to happen in isolation. People might get one seizure that lasts for a few minutes, and after they recover they might not have another for a long time. But sometimes seizures can happen in a rapid session. The seizure happens, it stops, and then a few minutes later another seizure happens—and this cycle can go on for a long time. When people have these cluster seizures, they are affected more severely and the recovery time is much longer. Sometimes if the clustering event isn’t stopped, it can progress into much longer seizures and neurological damage. That’s why we want to provide rescue medicine when cluster seizures start.

Does Nayzilam replace other medications or long-term treatment?

Nayzilam is purely a rescue treatment. The long-term treatments that people with epilepsy have to take will not be affected. That means those who are regularly taking seizure medications will still have to continue to take those medicines. Nayzilam will provide additional safety when they have cluster seizures or prolonged seizures.

When would Nayzilam be recommended?

People who have well-controlled epilepsy might not require rescue medication. But if their epilepsy is not well-controlled or they experience cluster seizures or longer seizures, they might be prescribed this rescue treatment.

If you or a loved one has epilepsy, talk to your doctor about your options. Need a doctor? Find one near you.