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Upsher-Smith Presents Favorable Phase I Data For USL261, A Novel Formulation Of Intranasal Midazolam, At 65th Annual Meeting Of The American Academy Of Neurology
Date:3/19/2013

MAPLE GROVE, Minn., March 19, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc., (Upsher-Smith) today announced that Phase I data for USL261 (intranasal midazolam) in healthy volunteers were presented at the Annual American Academy of Neurology (AAN) Meeting in San Diego, CA.   The results demonstrated that maximum 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.     

USL261 is a novel, investigational formulation of the benzodiazepine midazolam, 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.  It is intended to be administered by a caregiver without active inhalation by the patient.  USL261 is the subject of the ongoing, global Phase III ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) trial.  Additionally, there is an ongoing long-term, open-label safety study for patients who successfully complete the ARTEMIS1 trial.  More information about these studies can be found at http://www.clinicaltrials.gov (NCT01390220/NCT01529034).

Commented Barry Gidal , PharmD, RPH, Professor of Pharmacy and Neurology/
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SOURCE Upsher-Smith Laboratories, Inc.
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