Midazolam intranasal - Upsher-Smith

Drug Profile

Midazolam intranasal - Upsher-Smith

Alternative Names: ITI-111; Midazolam Nasal Spray - Upsher-Smith; USL-261

Latest Information Update: 09 Jun 2017

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At a glance

  • Originator Intranasal Therapeutics
  • Developer Upsher-Smith
  • Class Benzodiazepines; Hypnosedatives; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Seizures
  • New Molecular Entity No

Highest Development Phases

  • Phase III Seizures
  • Phase I Epilepsy
  • Discontinued Anaesthesia; Anxiety disorders; Mild cognitive impairment

Most Recent Events

  • 19 May 2017 Upsher-Smith terminates a phase III extension trial for Seizures (In adolescents, In adults) in USA, Canada, European Union, Australia, New Zealand and Ukraine (NCT01529034)
  • 26 Apr 2017 Proximagen announces intention to submit 505(b) NDA to US FDA for Seizures in the second half of 017 based on the results of its phase III ARTEMIS1 trial (915306)
  • 22 Apr 2017 Adverse events data from a phase I trial in Epilepsy presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017)
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