FDA News

FDA approves novel epilepsy drug

UCB announced that its benzodiazepine-based nasal spray for patients with epilepsy was recently approved by the FDA.

“Treating seizure clusters today presents a challenging barrier for many patients. The availability of a new treatment option, such as [midazolam] has potential to help improve the lives of patients and their families by providing another option for rescue care,” Steven S. Chung, MD, director of the epilepsy program at Banner-University Medical Center in Arizona, said in a company press release.

Nayzilam (midazolam) is a short-term, single-use, portable treatment intended for the acute treatment of intermittent, stereotypic episodes such as seizure clusters and acute repetitive seizure that are different from a patient’s usual seizure pattern. The medication is the first to be approved by the FDA for seizure clusters in 20 years and is the only FDA-approved nasal spray available for that indication, the release added.

A health care professional does not need to be present for the spray to be administered.

The release also stated that midazolam is intended for patients with epilepsy aged at least 12 years. The most common adverse events tied to its use were headache, throat irritation, somnolence, nasal discomfort and rhinorrhea. These occurred in 5% or more of patients, according to the release.

Disclosure: Healio Primary Care Today could not confirm relevant financial disclosures at the time of publication.

 

UCB announced that its benzodiazepine-based nasal spray for patients with epilepsy was recently approved by the FDA.

“Treating seizure clusters today presents a challenging barrier for many patients. The availability of a new treatment option, such as [midazolam] has potential to help improve the lives of patients and their families by providing another option for rescue care,” Steven S. Chung, MD, director of the epilepsy program at Banner-University Medical Center in Arizona, said in a company press release.

Nayzilam (midazolam) is a short-term, single-use, portable treatment intended for the acute treatment of intermittent, stereotypic episodes such as seizure clusters and acute repetitive seizure that are different from a patient’s usual seizure pattern. The medication is the first to be approved by the FDA for seizure clusters in 20 years and is the only FDA-approved nasal spray available for that indication, the release added.

A health care professional does not need to be present for the spray to be administered.

The release also stated that midazolam is intended for patients with epilepsy aged at least 12 years. The most common adverse events tied to its use were headache, throat irritation, somnolence, nasal discomfort and rhinorrhea. These occurred in 5% or more of patients, according to the release.

Disclosure: Healio Primary Care Today could not confirm relevant financial disclosures at the time of publication.