Neurelis has announced plans to conduct a clinical trial of Valtoco diazepam nasal spray in children with epilepsy aged 2-5 and said that the company intends to file an sNDA to expand the use of Valtoco to include this population sometime in 2021.
The FDA approved Valtoco for the treatment of seizure clusters in patients 6 years old and older in January 2020 and Neurelis launched the nasal spray in the US in March 2020. Valtoco is formulated with Neurelis’s Intravail transmucosal absortion enhancer which the company acquired when it acquired Aegis Therapeutics in December 2018.
Neurelis President and CEO Craig Chambliss commented, “There is a high unmet need in this younger age group for additional treatment options with a different route of administration that may be administered safely in the middle of a seizure emergency. We look forward to continuing to progress our efforts with the FDA to finalize the clinical requirements in this important group of patients.”
Read the Neurelis press release.
