NDA Submitted for Valtoco Nasal Spray to Treat Acute Repetitive Seizures
The product was previously granted Orphan Drug and Fast Track designation by the Agency.
The New Drug Application (NDA) for Valtoco (diazepam nasal spray; Neurelis) has been submitted to the Food and Drug Administration (FDA) for the treatment of acute repetitive seizures in patients ≥6 years old. The product was previously granted Orphan Drug and Fast Track designation by the Agency.
The Company states that the NDA is supported by robust clinical trial data, including patients studies where more than 1600 seizures were treated with Valtoco nasal spray. Currently, diazepam rectal gel is the only formulation of diazepam indicated for intermittent use in epilepsy to control bouts of increased seizure activity.
“It has been more than twenty years since a new therapy has been approved for the treatment of cluster or acute seizures," said Craig Chambliss Neurelis President and CEO. "This lack of novel and innovative therapies is a significant unmet need in the epilepsy community that needs to be addressed."
For more information visit Neurelis.com.