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Adamas Announces Additional ADS-5102 Data for the Treatment of Levodopa-induced Dyskinesia at the International Congress of Parkinson's Disease and Movement Disorders

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Additional Relevant Details ADS-5102 Extended-Release Capsules Reduced Levodopa-Induced Dyskinesia in the Phase 3 EASE LID Study; Abstract 2012 - Featured in ‘Berlin's Top Abstract' Display and Guided Poster TourAnalysis of data from EASE LID revealed a positive treatment effect for the ADS-5102-treated patients across all subgroups including: age, gender, renal function, and severity of motor complications (as measured at baseline). As previously reported, the Phase 3 EASE LID study met its primary endpoint with a highly statistically significant reduction in dyskinesia at week 12. The study also met all five pre-specified key secondary endpoints. Improvement in LID was observed at the first post-baseline assessment at week 2 and durable throughout the study (week 24 observation).  The efficacy of ADS-5102 was achieved without worsening the underlying PD. ADS-5102 was generally well tolerated, and the types of adverse events (AEs) reported were consistent with the known safety profile of amantadine.Interim Results of a Long-term Open-label Safety Study of ADS-5102 Extended-Release Capsules for Treatment of Levodopa-Induced Dyskinesia (EASE LID 2 Study); Abstract LBA 07The EASE LID 2 study is an open-label long-term safety study of ADS-5102. Enrollment was open to individuals who had completed prior participation in Adamas-sponsored LID studies, as well as individuals who, despite having undergone deep brain stimulation, had LID. The most common AEs in any group that occurred in at least five percent of patients included: falls, visual hallucinations, abnormal dreams, dizziness, peripheral edema, constipation and dry mouth. The types of AEs reported in this study were consistent with the known safety profile of amantadine and previous Adamas-sponsored randomized studies.  Of the patients from EASE LID who were naïve to ADS-5102 prior to this study, there were six (18%) who discontinued treatment due to AEs. This is comparable to that seen in previous controlled studies. For patients who continued ADS-5102 treatment from the prior 6-month controlled trial (EASE LID), there was one subject who discontinued due to AEs.This study, although designed to characterize the long-term safety and tolerability of ADS-5102, also generated non-controlled efficacy data. In the study, previously treated patients maintained their ADS-5102 reduction in motor complications for up to 41 weeks (as of the time of the first interim analysis). Additionally, patients who were naïve to ADS-5102 prior to this study also experienced a reduction in motor complications as observed at their first post-baseline assessment. These effects were achieved without compromising the underlying control of PD symptoms.  
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Occurred on:
Jun 22, 2016
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Related Keywords Ads-5102 Data, Levodopa-induced Dyskinesia, Parkinson's Disease, Movement Disorders