FDA approves diazepam nasal spray Valtoco
Neurelis has received the Food and Drug Administration’s green light for Valtoco (diazepam nasal spray). The nasal spray offers a new on-hand rescue treatment options for patients outside of the medical setting, Neurelis said.
Valtoco — indicated as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older — features a proprietary formulation of diazepam using Neurelis' transmucosal absorption enhancer Intravail. Previously, diazepam was only approved by the FDA in a rectal gel formulation.
“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. We are excited that we can now offer this treatment option to patients and provide additional support to the epilepsy community.”
The approval was welcomed by physicians who treat patients with epilepsy. R. Edward Hogan, director of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis, said, “This is an important development in the epilepsy community. 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."