"This additional open-label data further supports the long-term safety and efficacy of ADS-5102," said
This updated analysis of 223 patients provides open-label safety and tolerability data of ADS-5102 for naive and treated patients who were enrolled in the three placebo-controlled LID efficacy studies (EASED, EASE LID or EASE LID 3), as well as Parkinson's disease patients with LID who have undergone deep brain stimulation (DBS) treatment. These interim results expand on previously reported 41 week data. The types of adverse events (AEs) reported in this open-label study were consistent with the safety profile demonstrated in previous Adamas-sponsored randomized studies of ADS-5102 for LID in patients with Parkinson's disease. The most common adverse drug reactions that occurred in five percent or more of patients in any group included: falls, visual hallucinations, constipation, peripheral edema, nausea, dry mouth, livedo reticularis, and dizziness.
The results also confirm that the effect of ADS-5102 on LID and OFF time is maintained, as assessed by Part IV of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). These effects were achieved without compromising the underlying control of Parkinson's symptoms, as assessed by Parts I-III of the MDS-UPDRS.
About the EASE LID 2 Open-label Safety Study
The EASE LID 2 study is an ongoing Phase 3 open-label, long-term safety study of ADS-5102 for the treatment of LID in 223 patients with Parkinson's disease. The study enrolled patients from the three ADS-5102 placebo-controlled LID efficacy trials (EASED, EASE LID and EASE LID 3), as well as Parkinson's disease patients with LID who have undergone deep brain stimulation (DBS) treatment. Patients are being followed for up to two years. The primary objective of the study is to characterize the long-term safety and tolerability of ADS-5102 340 mg dosed once daily at bedtime for the treatment of LID in patients with Parkinson's disease. Secondary objectives include evaluating the durability of ADS-5102 on LID and OFF time as assessed by the MDS-UPDRS, as well as evaluating the clinical progression of Parkinson's disease.
ADS-5102 is a chrono-synchronous amantadine therapy with potential applications across a number of chronic neurologic disorders. Adamas is focusing initial development on the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. A New Drug Application (NDA) supporting ADS-5102 for the treatment of LID in patients with Parkinson's disease is under review by the
About Parkinson's disease and Levodopa-induced Dyskinesia
Parkinson's disease is a chronic neurodegenerative disorder affecting close to 1 million people in
Adamas is developing new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson's disease, multiple sclerosis, epilepsy and Alzheimer's disease. The company has pioneered a platform to develop medicines, called chrono-synchronous therapies, for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response to potentially achieve symptomatic relief without tolerability issues. The company's most advanced product candidate, ADS-5102, is in development for levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and walking impairment. An NDA supporting ADS-5102 for the treatment of LID in patients with Parkinson's disease is under review by the
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Statements contained in this press release regarding the expected benefits of ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' research, clinical and development activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' most recent Quarterly Report on Form 10-Q filed with the
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Martin ForrestVice President, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3528 firstname.lastname@example.org
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