Neurelis has received the US Food and Drug Administration (FDA) approval for its Valtoco (diazepam nasal spray) for the short-term treatment of seizure clusters in individuals aged two years and older.
Valtoco is a unique formulation of diazepam that employs INTRAVAIL technology to enhance intranasal delivery.
The absorption enhancement technology allows for the non-invasive administration of a wide range of drugs, including proteins, peptides, and small molecules.
The FDA approval marks a significant advancement in addressing acute repetitive seizures, which differ from a person’s typical seizure pattern.
Neurelis founder and CEO Craig Chambliss said: “We are so grateful for all those who participated in the clinical study to enable Valtoco to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures.”
Hackensack University Medical Centre Northeast regional epilepsy group paediatric epilepsy director Eric Segal said: “The FDA’s decision to approve Valtoco for use in early childhood highlights the established balanced safety and efficacy profile.
“Valtoco fills a large unmet need for children with seizures and their families. I am hopeful that this product will improve quality of life for this specific population.”
The FDA previously recognised Valtoco’s intranasal formulation as clinically superior to the rectal gel version, granting it orphan drug exclusivity.
Data from the Phase 1/2a clinical study demonstrated Valtoco’s safety and efficacy for patients aged two years and older.
The nasal spray medication provides a convenient and effective treatment option for those experiencing frequent seizures.
Harvard Medical School neurology associate professor Jurriaan Peters said: “For children who have episodes of frequent seizures, the current standard of care requiring rectal administration of medication to stop a seizure can be a significant challenge for caregivers and children alike.
“Approval of an immediate-use intranasal diazepam treatment that can be given at any time, even while a child is actively seizing, in this young age group is an important advance for the epilepsy community.”
