-- New subgroup analyses showed that patients previously treated with amantadine IR received benefit of ADS-5102 comparable to patients previously treated with placebo --
-- New Drug Application supporting ADS-5102 for the treatment of levodopa-induced dyskinesia currently under
"These long-term, open-label data are encouraging for physicians and their patients who are suffering from dyskinesia," said Dr.
"The expanded analysis out to 88 weeks provides continued support for the long-term safety and tolerability of ADS-5102, as evidenced by a minimal discontinuation rate, and the maintenance of a reduced and nearly constant level of dyskinesia and OFF for over 12 months, as measured by MDS-UPDRS, Part IV," said
Expanding on previously reported 64-week data, this updated analysis demonstrated that the treatment effect of ADS-5102 on motor complications, as accessed by MDS-UPDRS, Part IV (a measurement of dyskinesia, OFF and dystonia), was durable and maintained at a constant level for up to 88 weeks. Among patients previously treated with amantadine IR, switching to open-label ADS-5102 provided a 3 point, statistically significant reduction in MDS-UPDRS Part IV at Week 8. The treatment effect experienced by patients previously treated with amantadine IR was similar to that experienced by previous placebo-treated patients, and was maintained for up to 64 weeks. Patients who have undergone prior DBS treatment and were switched to open-label ADS-5102 also demonstrated a comparable reduction in the MDS-UPDRS, Part IV. All subgroups achieved reductions in motor complications without compromising the underlying control of Parkinson's symptoms, as assessed by Parts I-III of the MDS-UPDRS.
The safety data are consistent with the previously reported safety profile of ADS-5102 and the known safety profile of amantadine, which includes precautions and warnings related to suicidality, hallucinations and dizziness. Approximately 50% of discontinuations due to adverse events (AEs) occurred within the first month of treatment. The most common AEs, occurring in five percent or more of patients in any group, included falls, visual hallucinations, peripheral edema, constipation, livedo reticularis, nausea, dry mouth, insomnia and dizziness.
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 levodopa-induced dyskinesia (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 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 motor complications (dyskinesia and OFF) as assessed by the MDS-UPDRS, Part IV, as well as evaluating the clinical progression of Parkinson's disease.
ADS-5102 is a high-dose amantadine, taken once daily at bedtime, in development for the treatment of LID in people with Parkinson's disease. A New Drug Application (NDA) supporting ADS-5102 for the treatment of LID in people 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
Levodopa, which replaces lost dopamine, is the most effective therapy for all stages of Parkinson's disease and is considered the "gold standard"
therapy. Over time, people require increasingly higher or more frequent doses of levodopa in order to avoid the recurrent periods of OFF time when the underlying symptoms of Parkinson's disease return. As Parkinson's disease progresses, nearly all people on levodopa therapy will also experience LID, which is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable. Symptoms of OFF time are characterized by slowness of movement, rigidity, impaired walking, tremor and postural instability. These people often experience multiple fluctuating periods of OFF time and LID during any given day, which can impede their movement and daily function. In
Adamas develops 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. Adamas has pioneered a platform to develop medicines for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response. The company's most advanced product candidate, ADS-5102, is a high-dose amantadine, taken once daily at bedtime, in development for levodopa-induced dyskinesia in people with Parkinson's disease and for the treatment of walking impairment in people with multiple sclerosis. A New Drug Application supporting ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease is under review by the
NAMENDA XR® and NAMZARIC® are
Statements contained in this press release regarding matters that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding the potential approval of ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease and the potential clinical benefits of ADS-5102. 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, development and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the
Martin ForrestVice President, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3528 Ashleigh BarretoDirector, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3567 firstname.lastname@example.org
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