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Upsher-Smith Announces Patient Enrollment In Open-label Safety Study Of USL261 (Intranasal Midazolam) For Rescue Treatment Of Seizure Clusters In Epilepsy
Date:6/24/2013

tment of seizure clusters.  We are pleased to offer eligible patients access to USL261 during this study period as this will help to inform the safety profile of the product."

"Seizure emergencies, such as repetitive seizures and seizure clusters, are serious medical events requiring immediate treatment to reduce the risk of morbidity and mortality," said Robert T. Wechsler, MD, PhD, FAAN, Medical Director, Idaho Comprehensive Epilepsy Center.  "There is a significant need for new therapies to treat seizure clusters.  Currently, only one medication is FDA-approved for intermittent bouts of increased seizure activity outside of the hospital setting, and it must be delivered rectally, which may be undesirable to some individuals."

Favorable Phase I data for USL261 in healthy volunteers were recently presented at the Annual Meeting of the American Academy of Neurology in March 2013.  The results demonstrated that peak midazolam plasma concentrations were rapidly achieved (10-15 min) after dosing with USL261.  USL261 also demonstrated increased absorption with an improved bioavailability compared to an equivalent dose of injectable midazolam delivered intranasally.  Single doses of USL261 up to 7.5 mg were generally well tolerated.     

About ARTEMIS1
ARTEMIS1, a Phase III randomized, double-blind, placebo-controlled study, is designed to assess the efficacy, safety and tolerability of USL261 in males and females ages 14 to 65 years with seizure clusters.  Study medication is administered intranasally without active inhalation by the patient.

The primary efficacy endpoint of the study is Treatment Success, which is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) within four hours after study drug administration.

To be eligible for t
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SOURCE Upsher-Smith Laboratories, Inc.
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