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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

MAPLE GROVE, Minn., June 24, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc., (Upsher-Smith) today announced that it is enrolling patients in its open-label safety extension study to ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), a global Phase III clinical trial for USL261, a novel, investigational formulation of the benzodiazepine midazolam.  USL261 is delivered intranasally for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters or acute repetitive seizures.  The open-label, multicenter study will evaluate the long-term safety and tolerability of USL261 in the treatment of seizure clusters.  USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA) and Upsher-Smith will be seeking approval for this indication.

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More information about the open-label extension study, including key eligibility requirements, is available at www.clinicaltrials.gov (NCT# 01529034).  

"At Upsher-Smith, we are dedicated to researching new treatment options for people living with challenging central nervous system conditions like epilepsy," said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith.  "In this open-label safety extension study, patients receiving both placebo and study medication in ARTEMIS1 will have the opportunity to utilize USL261 for the rescue trea
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SOURCE Upsher-Smith Laboratories, Inc.
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