Neurelis today said it won FDA approval for its Valoco seizure rescue nasal spray.
Valtoco is approved to use by a care partner outside of a medical setting to treat intermittent, stereotypic episodes of seizure activity. It is designed for people with epilepsy aged 6 or older. Valtoco also uses the company’s Intravail formula for consistent and reliable absorption.
“Cluster or acute repetitive seizures are challenging to treat and highly disruptive in the lives of people with epilepsy,” president and CEO Craig Chambliss said in a news release. “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. We are excited that we can now offer this treatment option to patients and provide additional support to the epilepsy community.”
Valtoco was also granted seven years of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development, according to Neurelis.
The company’s Intravail transmucosal absorption enhancement technology allows for the non-invasive delivery of a broad range of protein, peptide and small molecule drugs.
“This is an important development in the epilepsy community,” Edward Hogan, director of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis, said. “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 closer or acute repetitive seizures and their care partners.”