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

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

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 12 Sep 2024

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At a glance

  • Drugs Dexamfetamine (Primary) ; Lisdexamfetamine
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 04 Sep 2024 According to Collegium Pharmaceutical media release, Ironshore Pharmaceutical and Development has been acquired and merged into Collegium Pharmaceutical.
    • 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

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