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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

Division Chair, University of Wisconsin, "The data presented at AAN from the development program for USL261 support the safety profile and favorable pharmacokinetics/pharmacodynamics of USL261 in healthy volunteers.  These findings support the further development of USL261 for seizure rescue in patients with intermittent bouts of increased seizure activity, a population for which few treatment options are currently available."

USL261 (Intranasal Midazolam) Data  

USL261 data presented at AAN 2013 examined the pharmacokinetics, pharmacodynamics, safety, and tolerability of USL261 in healthy volunteers.  In this study, increasing USL261 doses corresponded with an apparent linear increase in midazolam exposure, with all doses demonstrating rapid time to maximal plasma concentration (10 – 15 min).  Researchers concluded that USL261 dosed up to 7.5 mg was generally well tolerated and did not result in excessive or prolonged sedation or psychomotor impairment.  Further, when compared with an equivalent dose of injectable midazolam delivered intranasally, USL261 demonstrated improved midazolam bioavailability with similar pharmacodynamic effects and safety/tolerability profiles.  

Abstracts of the poster presentations can be found online at: http://www.aan.com 

  • Safety and Pharmacodynamics of USL261, a Novel Formulation of Midazolam Optimized for Intranasal Administration
    P02.211. Session P02:  Epilepsy:  Novel Therapeutics and Basic Science
  • Pharmacokinetics of USL261, a Novel Formulation of Intranasal Midazolam
    P02.212. Session P02:  Epilepsy:  Novel Therapeutics and Basic Science

About Epilepsy

Epilepsy is a medical condition that causes seizures affecting a variety of cognitive and physical functions.  More than two million
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