13 January 2020 – Congratulations to Neurelis on their recent NDA approval for seizure rescue treatment VALTOCO® (Diazepam nasal spray). PLC has supported the clinical development and regulatory pathway of VALTOCO from the beginning and supported their IND and NDA filings. In addition, PLC supported the development and filing of the Orphan Drug Exclusivity for VALTOCO to the US FDA. PLC looks forward to their continued support of VALTOCO post approval.
NEURELIS ANNOUNCES FDA APPROVAL FOR SEIZURE RESCUE TREATMENT VALTOCO® (DIAZEPAM NASAL SPRAY) THAT INCORPORATES THE SCIENCE OF INTRAVAIL® FOR CONSISTENT AND RELIABLE ABSORPTION
- VALTOCO (diazepam nasal spray) is approved by the U.S. Food and Drug Administration (FDA) for use by a care partner outside of the medical setting for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern
- VALTOCO is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 and older
- VALTOCO’s proprietary formulation including Intravail®has been shown to be generally safe and well tolerated
- VALTOCO granted Orphan Drug Exclusivity by the FDA