UMN Research Team Supported the Development of New Seizure Drug Treatment
Last month, VALTOCO — a nasal diazepam spray designed as a rescue therapy for patients with epilepsy who have seizure clusters — received FDA approval.
In collaboration with the drug’s manufacturer, Neurelis, Dr. Jim Cloyd, professor and director of the Center for Orphan Drug Research at the University of Minnesota College of Pharmacy, and Dr. Bob Kriel, an adjunct professor in the College of Pharmacy, undertook a key study needed for FDA approval. Neurelis initially reached out to Dr. Cloyd and Dr. Kriel because of their previous work with U of M students in the 2000s that demonstrated that nasal administration of diazepam solutions was feasible. VALTOCO’s FDA orphan drug designation application was also co-authored by Dr. Cloyd, who assisted Neurelis with other clinical study analysis.
A rectal gel diazepam formulation developed by Upsher Smith Laboratories, in partnership with Dr. Cloyd and Dr. Kriel, and diazepam was previously the only FDA-approved product for seizure clusters. The availability of an intranasal formulation of diazepam provides a new, on-hand and easily administered rescue treatment option for patients or their caregivers that can be used outside of the medical setting – wherever and whenever they need it.