Neurelis Nabs Orphan Drug Designation for Valtoco

The FDA gave Neurelis Pharmaceuticals’ Valtoco (diazepam nasal spray) orphan drug designation for the management of acute repetitive seizures.

The agency granted the designation based on its intranasal route of administration, which it deemed clinically superior to the alternative rectal route of administration, noting that the nasal spray demonstrates a “significantly improved ease of use.”

Valtoco was approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients six years of age and older with epilepsy.