Midazolam intranasal - Upsher-Smith

Drug Profile

Midazolam intranasal - Upsher-Smith

Alternative Names: ITI-111; USL-261

Latest Information Update: 02 May 2017

Price : $50

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

  • 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)
  • 01 Mar 2017 Upsher-Smith Laboratories terminates phase III trial in Seizures (In adolescents, In adults) in US, Canada, Germany, Hungary, Italy, Poland, Spain, Ukraine, Israel, Australia and New Zealand (NCT01390220)
  • 28 Oct 2016 Phase-I clinical trials in Epilepsy (In children) (Intranasal) before October 2016
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