Objective: An objective of this study was to evaluate the long-term duration of ADS-5102 effect on dyskinesia as assessed by the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV. The primary objective of the study was safety and tolerability and will be presented in a complimentary abstract.

Background: ADS-5102 (amantadine) extended release capsules (GOCOVRITM, 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, open-label study conducted in North America and Western Europe (NCT02202551), PD patients with dyskinesia received 274 mg of ADS-5102 once daily at bedtime for up to two years. Eligible patients 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). Changes to background PD medications, including levodopa preparations, were allowed during this open-label study. The primary outcome measure was safety and tolerability using standard safety assessments. Efficacy was assessed using the MDS-UPDRS, Part IV.

Results: In this final analysis, 223 patients received ADS-5102 for a mean duration of approximately 540 days. By the first post-baseline visit (Week 8), MDS-UPDRS, Part IV scores were reduced by approximately 3 to 4 units across all groups naïve to ADS-5102 treatment, including those with prior DBS and previous amantadine IR treatment, with effects lasting out to 2 years. For the cohort of patients enrolled from the 24-week EASE LID study, the treatment effect seen in the double-blind study was maintained out to a total of 124 weeks. Lastly, at 1 and 2 years of treatment, 23% and 30% of patients, respectively, had increased their levodopa dose from baseline. The most common AEs included hallucinations, dry mouth, dizziness, and peripheral edema.

Conclusions: ADS-5102 demonstrated a durable effect in MDS-UPDRS, Part IV in all groups out to the 2 year follow up visit, even when daily levodopa dose increased. Safety data was consistent across groups and is discussed in detail in a complimentary abstract.

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