Pamela J. Davis
Added Dr. Davis, "Eligible patients who participate in the ARTEMIS1 trial will receive study drug and office visits at no cost. Patients and caregivers will receive travel reimbursement, and caregivers will receive additional training."
USL261 (midazolam) is a benzodiazepine in an investigational formulation that is delivered intranasally. It is intended to be administered by a caregiver in an outpatient setting for the rescue treatment of seizure clusters. USL261 does not require active inhalation by the patient.
ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), a Phase III randomized, double-blind, placebo-controlled study, compares USL261 with an intranasal placebo in males and females ages 14 to 65 years. To be eligible for the trial, participants must have a diagnosis of seizure clusters and must have an adult caregiver who can recognize, observe and record seizure cluster episodes and who is willing to be trained in the study procedures, among other criteria. The seizure clusters must have a pattern that is different from the individual’s other non-cluster seizure activity and must be recognizable by the caregiver.
USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA). Upsher-Smith owns the exclusive global rights to USL261.
About Seizure Clusters
Seizure clusters, also referred to as acute repetitive seizures, are multiple seizures which occur over a relatively brief period of time with a pattern distinguishable from the usual seizure pattern.(1) Typically, there is recovery between seizures.(2)
Estimates of seizure cluster prevalence vary, but it has been estimated that approximately 22% of the intractable epilepsy population (approximately 152,000 people) experience them.(3,4,5,6)
Inadequate treatment of seizure clusters can potentially impact the safety of an epilepsy patient, may result in emergency room visits, and/or may evolve into status epilepticus, a potentially life-threatening condition.(7,8,9)
Market research has shown that patients and caregivers prefer a rescue medication for seizure clusters that can be administered in any setting, and provides effective and rapid seizure termination in an easy-to-use, non-invasive form of administration.(10)
Epilepsy is a medical condition that causes seizures affecting a variety of cognitive and physical functions. An estimated three million people in the U.S. have some form of epilepsy with about 200,000 new cases of epilepsy diagnosed each year.(11)
Upsher-Smith’s Expanding CNS Pipeline
Upsher-Smith’s central nervous system (CNS) pipeline includes a number of investigational drug programs. In addition to USL261 (intranasal midazolam), USL is developing USL255 (extended-release topiramate) for the management of epilepsy in adults, which is being studied in an ongoing international Phase III clinical trial (PREVAIL). Another Upsher-Smith development program involves USL260 (tonabersat), an investigational drug and potential first-in-class neuronal gap junction modulator that is also being explored as a potential treatment for epilepsy.
N Engl J Med
Curr Treat Options Neurol
N Engl J Med.
Annals of Neurology
Epilepsy & Behavior
Epilepsy Patient and Caregiver Insights and Reactions to a New Rescue Medication
SOURCE Upsher-Smith Laboratories, Inc.