The US Food and Drug Administration (FDA) has approved Neurelis’ diazepam nasal spray, Valtoco, for the short-term treatment of acute repetitive seizures, also referred to as seizure clusters, in patients aged two years and above.
The spray leverages a transmucosal absorption enhancement technology, Intravail, for noninvasive intranasal diazepam delivery.
This technology facilitates the delivery of proteins, small-molecule drugs and peptides.
The FDA had previously awarded the treatment its orphan drug exclusivity designation by recognising the superiority of Valtoco’s intranasal formulation to diazepam’s rectal gel formulation.
3.4 million US adults with epilepsy and 400,000 paediatric patients experience acute repetitive seizures.
The Phase I/IIa trial assessing the pharmacokinetics and safety of the spray has shown that it is effective and safe via nasal administration for subjects aged two years and above.
Neurelis develops and commercialises treatments for epilepsy and neurological conditions with unmet medical needs.
The spray is not authorised for use in infants or neonates. The use of benzyl alcohol-preserved medications in these populations can lead to fatal adverse events, including gasping syndrome, marked by metabolic acidosis, central nervous system depression and gasping respiratory patterns.
Neurelis CEO and founder Craig Chambliss stated: “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".
