A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Phase of Trial: Phase III
Latest Information Update: 04 Apr 2016
At a glance
- Drugs Lisdexamfetamine (Primary)
- Indications Binge-Eating Disorder
- Focus Registrational; Therapeutic Use
- Sponsors Shire Pharmaceuticals
- 22 Jul 2015 Based on the results of this trial, as well as findings from other study (see profile 224561), the Company plans to submit a sNDA to the U.S. FDA by year end 2015. The FDA will evaluate adding these data to the current labeling for Vyvanse, according to a Shire media release.
- 22 Jul 2015 Top-line results were published in the Shire Media Release.
- 27 Apr 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.