Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study).

Trial Profile

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study).

Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 Feb 2017

At a glance

  • Drugs Amantadine (Primary)
  • Indications Drug-induced dyskinesia; Parkinson's disease
  • Focus Therapeutic Use
  • Acronyms EASED
  • Sponsors Adamas Pharmaceuticals
  • Most Recent Events

    • 08 Jan 2017 According to an Adamas Pharmaceuticals media release, the New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017.
    • 27 Oct 2016 According to an Adamas Pharmaceuticals media release, based on the data from this and EASE LID, EASE LID 2 and EASE LID 3 the company submitted an NDA of amantadine hydrochloride extended-release capsules to US FDA for the treatment of patients with Parkinsons disease.
    • 28 Apr 2016 According to an Adamas Pharmaceuticals media release, the company expects to submit an NDA in 2016 and, assuming FDA approval, launch the product in 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top