FDA OKs first nasal spray to treat epilepsy

Jan. 14, 2020

Neurelis's Valtoco(diazepam nasal spray) has been approved by the U.S. Food and Drug Administration for use by a care partner outside of the medical setting for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern. It is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 and older.

"Cluster or acute repetitive seizures are challenging to treat and highly disruptive in the lives of people with epilepsy," said Neurelis president and CEO Craig Chambliss. :Valtoco was developed to provide an effective combination of reliability, safety and tolerability in a ready-to-use nasal spray. This is a defining moment for Neurelis as Valtoco is our first FDA-approved product.”

Valtoco has also been granted seven years of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development.

"This is an important development in the epilepsy community,” said R. Edward Hogan, MD, eirector of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis. "Most seizures that require intervention are treated in an inconvenient manner. To be able to reliably treat seizure activity when and where it happens with a caregiver-administered option like VALTOCO is a significant step forward. The availability of VALTOCO may positively impact the lives of thousands of people with epilepsy who experience cluster or acute repetitive seizures and their care partners."

In a long-term, open-label, repeat dose, clinical trial, the safety of VALTOCO was evaluated: over 130 patients were enrolled and more than 2,000 seizures were treated. The clinical trial included patients aged 6 and above. “Until recently, approved treatment outside of medical care settings was only available as a rectally administered medication,” Dr. Hogan said. “The FDA approval of diazepam nasal spray is a significant advancement for the epilepsy community.”

Read the full Neurelis release