Objective: The primary objective of this study was the safety and tolerability of ADS-5102 in PD patients with dyskinesia. Secondary efficacy outcome measures included MDS-UPDRS, Part IV and are covered in a complimentary abstract.

Background: ADS-5102 (amantadine) extended release capsules (GOCOVRI, Adamas Pharmaceuticals, Inc.) is a treatment for dyskinesia in patients with Parkinson’s disease (PD). ADS-5102 reduced dyskinesia and OFF time in phase 3 controlled trials of up to 6 months. Amantadine immediate release (IR) is used for dyskinesia, but suboptimal durability and tolerability limit its clinical utility.

Methods: In this completed, two-year, open-label study conducted in North America and Western Europe (NCT02202551), PD subjects with dyskinesia received 274 mg of ADS-5102 once daily at bedtime for up to two years. Eligible subjects included those with dyskinesia who had undergone DBS and those continuing or initiating ADS-5102 treatment following their participation in a prior placebo-controlled LID efficacy study (EASED, EASE LID or EASE LID 3). In addition, a cohort of patients entered the study while taking amantadine IR and were directly transitioned to ADS-5102 at entry. The primary outcome measure was safety and tolerability using standard safety assessments.

Results: In this final analysis, 223 subjects received ADS-5102 for a mean duration of approximately 540 days. The most common adverse events (AEs) (>10% in any group) included falls, hallucinations, peripheral edema, constipation, and dizziness. Approximately 20% of subjects discontinued dosing due to an AE. A Kaplan-Meier analysis demonstrated that treatment discontinuations due to AEs was mostly in the first few months of treatment and tapered off significantly after that. The most common AE that led to discontinuation was hallucinations (N=6, 3%). The time to onset of adverse events was reviewed and while hallucinations mostly occurred in the first month of treatment, adverse events of livedo reticularis and peripheral edema were mostly observed after 2 months of treatment.

Conclusions: ADS-5102 was generally well tolerated across all groups and AEs were consistent with the safety data reported from previous double-blind ADS-5102 studies. For subjects that entered the study on DBS and/or amantadine IR, safety data was consistent with data for patients previously participating in the controlled trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/final-safety-results-of-ease-lid-2-study-long-term-open-label-study-of-ads-5102-for-dyskinesia-in-parkinsons-disease-pd-patients/