The use of nasal sprays for the treatment of epilepsy has gained considerable attention lately. At this past May’s American Academy of Neurology (AAN) meeting, Washington University epileptologist R. Edward Hogan, MD, presented two posters outlining the use of diazepam nasal spray. This was followed a few weeks later by the US Food and Drug Administration (FDA) approving midazolam nasal spray (Nayzilam) for the treatment of acute repetitive seizures distinct from a patient’s usual seizure pattern.
Medscape contributor Andrew Wilner, MD, spoke with Hogan about how the field came to embrace nasal spray solutions for epilepsy and what may change in the wake of recent data and FDA approval.
The Rationale for Intranasal Treatments
With the recent FDA approval of midazolam, can you give us the background on this treatment and how it’s going to help our patients?
In the big picture, we’re lucky to have a number of antiepileptic medications that are effective. Despite that, probably 20%-30% of patients continue to have seizures, no matter what medicines we give them.
Typically, we’ve given medications at a specified time of the day, every day. The idea is that that background medication will control the seizures. However, the difficulties arise when those don’t work. We know that after you’ve tried two or three antiepileptic medications, the chances of another long-term medicine helping really go down. The other thing that happens is that when you move to that second or third medication, the side effects tend to go up quite a bit.
So the idea behind these new treatments is not that they’re given every day, but they’re something we can give when there is an occasion that people need more medications. It has been well established that some people tend to have seizures in clusters, where, if they only have one seizure, then it’s very likely that they’ll have another one within a few hours. The concept of being able to give an additional medication when there’s a pattern to the seizures has been out there for quite some time.
For almost 30 years now, we have had an approved treatment for these kinds of seizures, which is rectal diazepam. Although that is an effective medication, it’s not ideal—obviously, especially in an adult population. So the idea has really been to find dosage forms of medications that we can administer quickly and reliably, and that can be used in this seizure pattern, where people can take an extra dose of medicine.
Several medicines have been tried for this over the years, but some of the ones that have really been on the forefront have been intranasal midazolam, which was just approved, and then I did some trials with intranasal diazepam, which is also an effective agent, potentially.
We’re really using agents that we know well. Midazolam and diazepam, which is Valium, are well-known molecules, but we want to introduce them intranasally, which is not the usual route. The nose is highly vascular, so the nasal mucosa has the potential to absorb a medication rapidly. Is that the concept?
That’s exactly right—that it’s easy to give and reliably absorbed. People can try to put a pill in and have it dissolve in their mouth, or there are other ways to try to get a medication in, but to do it reliably in a way that you can count on the medicine getting in relatively quickly is ideal. The nasal route makes that possible.
SOURCE: By Andrew Wilner, MD for MedScape