Trial Profile
A phase 2b/3 study of HLD100 with lisdexamfetamine (Vyvanse) as a comparator
Status:
Planning
Phase of Trial:
Phase II/III
Latest Information Update: 18 Apr 2017
Price :
$35
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At a glance
- Drugs Dexamfetamine (Primary) ; Lisdexamfetamine
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- 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