The U.S. Food and Drug Administration (FDA) has announced the approval of Valtoco (diazepam nasal spray) for the treatment of seizure clusters in patients with a history of epilepsy aged 6 years and above.
Developed by Neurelis, Valtoco may be administered nasally by a caregiver outside of a medical setting for the acute treatment of seizure clusters.
Seizure clusters are a form of seizures that start and stop. They occur in clusters or groups with one episode right after another.
The FDA approved the formulation of this nasal spray as a rescue treatment for patients with epilepsy aged 6 years and above, according to Neurelis, a neuroscience-based pharmaceutical company.
In May 2019, the FDA approved Nayzilam (midazolam nasal spray) for patients with a history of epilepsy aged 12 years and above.
The drug regulatory body approved Valtoco after evaluating the safety and efficacy of the nasal spray based on the results of a clinical trial. The trial was conducted on 130 patients aged 6 and above who successfully underwent treatment for more than 2,000 seizure clusters with diazepam nasal spray.
Generally, the drug was found to be safe and well-tolerated. Some of the most common side effects of Valtoco were headaches, nasal discomfort, and sleepiness.
In the United States, more than 170,000 patients with epilepsy are at risk of seizure clusters, according to Neurelis.
Before the approval of Nayzilam and Valtoco, the FDA-approved rescue medications for seizure clusters were administered through the rectum.
If needed, patients can have a second dose of Valtoco four hours after the initial dose. However, it should not be used more than twice for a single episode of seizure. The FDA recommends that diazepam nasal spray should not be used for more than one seizure episode every 5 days and more than five episodes per month.