Neurelis said that it has initiated the Stellina Phase 1/2a trial of Valtoco diazepam nasal spray in epilepsy patients between the ages of 2 and 5. The news comes almost exactly one year after the company announced plans for the pediatric trial and a future sNDA submission. Valtoco has been approved in the US for the treatment of seizure clusters in patients 6 years old and older since January 2020.
In March 2021, Neurelis announced that it had raised $114 million to fund commercialization of Valtoco and continued development of its pipeline which also includes nasal sprays for the treatment of panic attacks and agitation associated with psychiatric disorders such as schizophrenia or bipolar mania.
Neurelis Senior VP of Clinical Development and Medical Affairs Adrian L. Rabinowicz said, “Currently the only FDA-approved option for these children is a rectally administered version of diazepam. We understand that caregivers and physicians treating these younger seizure cluster patients could benefit from having a more convenient, nasally-administered rescue therapy that can be used on the go.”
Read the Neurelis press release.
