A phase 2b/3 study of HLD100 with lisdexamfetamine (Vyvanse) as a comparator

Trial Profile

A phase 2b/3 study of HLD100 with lisdexamfetamine (Vyvanse) as a comparator

Planning
Phase of Trial: Phase II/III

Latest Information Update: 12 Apr 2017

At a glance

  • Drugs Amfetamine (Primary) ; Lisdexamfetamine
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, based on the results from HLD100-103 trial (see profile 276130), reviewed at an End of Phase 2 meeting with the FDA and based on the feedback company is pursuing for this and other pivotal trial (see profile 269841).These two pivotal trials will support of a New Drug Application with a differentiated label. Company intends to initiate the pivotal trials in the third quarter of 2017, with a NDA expected in 2018.
    • 18 Sep 2016 New trial record
    • 26 Aug 2016 According to a Highland Therapeutics media release, based on data from HLD100-103 (see profile 276130) study, and on continued feedback and dialogue with the FDA, Ironshore anticipates initiating this phase 2b/3 study with Vyvanse
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