23th Sep 2020 – Neurelis, Inc.
issued an announcement, which is summarized as follows：
Neurelis, Inc., today announced that it will be
investigating the safety and pharmacokinetics of the company’s lead product,
VALTOCO® (diazepam nasal spray), in children with epilepsy aged two to five.
VALTOCO is currently available for adults and pediatric patients 6 years of age
and older. This is an investigational program for a patient population not
included in the current U.S. Food and Drug Administration-approved (FDA)
VALTOCO label. VALTOCO was approved by the FDA on January 10, 2020, for the
acute treatment of intermittent, stereotypic episodes of frequent seizure
activity (ie, seizure clusters, acute repetitive seizures) that are distinct
from a patient’s usual seizure pattern.
“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,” said Craig Chambliss, the company’s President and Chief
Executive Officer. “We look forward to continuing to progress our efforts
with the FDA to finalize the clinical requirements in this important group of
patients.”
Upon completion of the clinical study, Neurelis
plans to submit a supplemental NDA (sNDA) with the FDA to expand VALTOCO’s
label to include patients aged 2 and older. Chambliss said the company plans to
file the sNDA in 2021.
The original website link：
https://www.neurelis.com/neurelis-news/neurelis-announces-program-to-investigate