A pivotal trial of amphetamine (HLD-100) for the treatment of attention deficit hyperactivity disorder

Trial Profile

A pivotal trial of amphetamine (HLD-100) for the treatment of attention deficit hyperactivity disorder

Planning
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2017

At a glance

  • Drugs Amfetamine (Primary)
  • 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 276138). These two pivotal trials will support of a New Drug Application with a differentiated label. Company intends to initiate the these trials in the third quarter of 2017, with a NDA expected in 2018.
    • 15 Dec 2016 According to a Ironshore Pharmaceutical media release, company plans to initiate this study in 2017.
    • 15 Dec 2016 Planned initiation date changed from 1 Jul 2016 to 1 Jan 2017 as per Ironshore Pharmaceutical media release.
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