In This Underserved Arena, What Clinical Attributes Will Be Most Persuasive for Neurologists and Payers Regarding Novel Outpatient Rescue Therapies?
Acute repetitive seizures (ARS)—also known as serial, recurrent, or cluster seizures—is a phenomenon in treatment-refractory epilepsy that is characterized by a close temporal association of seizures that exceeds a patient’s typical baseline seizure frequency. ARS poses a risk of hospitalization and/or evolution into status epilepticus, a life-threatening seizure emergency, which underscores the need for early, effective management. Benzodiazepines are typically used as needed for rescue treatment in this orphan indication, being prescribed adjunctively to patients’ chronic antiepileptic drug (AED) regimen and administered on an as-needed basis. However, treatment in the outpatient setting (e.g., by a caregiver) is underserved by current options, particularly in the United States, where the lone FDA-approved outpatient therapy—rectal diazepam (Valeant Pharmaceuticals’ Diastat, Wakodo’s Diapp, generics)—bears obvious and significant delivery shortcomings. As such, a recognized unmet need exists for additional safe, effective, easier-to-administer outpatient rescue therapy alternatives for the treatment of ARS.