Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease.

ABSTRACT:

Background

Although levodopa is considered the most effective pharmacotherapy for motor symptoms of Parkinson's disease (PD), chronic use is associated with motor complications, including fluctuating response and unpredictable, involuntary movements called dyskinesia. ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRI^TM) is a recent US FDA-approved treatment for dyskinesia in PD patients. ADS-5102 is a high-dose, ER formulation of amantadine, administered orally once daily at bedtime, that achieves high plasma drug concentrations throughout the day.

Objective

In this study, we present pooled results from two randomized, double-blind, placebo-controlled, phase III ADS-5102 trials.

Patients and methods

The two studies in PD patients with dyskinesia

SUBMITTER: Elmer LW 

PROVIDER: S-EPMC5934466 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature