FDA News: Nayzilam (midazolam) Nasal Spray Approved for Seizure Clusters

Epilepsy News From: Tuesday, May 21, 2019

The U.S. Food and Drug Administration approved the use of NAYZILAM® (midazolam) nasal spray CIV this week for use in children age 12 and over and adults with epilepsy.

  • Nayzilam is a rescue therapy for acute (immediate, short-term) treatment of intermittent, stereotypic episodes of frequent seizure activity. This means that the medicine can be used to treat seizure clusters, bouts of increased seizures, or acute repetitive seizures (ARS).
  • It can be given by a non-medical person outside of a hospital setting – when a person needs it!
  • It’s a nasal spray that can be given easily by the person with epilepsy between seizures. Or it can be given by someone else to a person during a seizure.
  • Nayzilam (midazolam) is from a group of drugs called benzodiazepines. It is very good at stopping seizures quickly when used intermittently or “as needed” for specific situations.
  • It is NOT approved as a seizure medicine to be used on a daily basis. And, it should not take the place of a person’s usual seizure medication.

The Importance of This New Rescue Therapy Option

This is the first rescue therapy for epilepsy since 1997 when Diastat (diazepam rectal gel) was approved. Rescue therapies can be critical to help stop periods of seizures that could lead to seizure emergencies, hospitalizations and early death. They can make a huge difference in the lives of people with epilepsy and their families.

While Diastat is very effective, it is given rectally, which limits its use in social settings. Nayzilam appears to be a highly effective option, which can be given by a much more socially acceptable route, particularly for teens and adults with epilepsy – Elaine Wirrell, co-editor-in-chief of epilepsy.com

Coming Soon

Stay tuned for more information about rescue therapies for epilepsy. The Epilepsy Foundation is working with our partners to expand awareness and practices of rescue therapies for the epilepsy community.

Authored by

Epilepsy Foundation Health Communications

Reviewed Date

Tuesday, May 21, 2019

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