--Placebo-Controlled Phase 3 Trial Demonstrated that ADS-5102 Significantly Reduced Both Dyskinesia and OFF Time at Six Months in Parkinson's Disease Patients with Levodopa-induced Dyskinesia --
-- New Drug Application for ADS-5102 Currently Under FDA Review with
"ADS-5102 reduced the duration, severity, and impact of dyskinesia in people with Parkinson's disease. These statistically significant reductions were maintained for the entirety of the six-month EASE LID study," stated
"ADS-5102, if approved, will be an important advancement in the treatment of Parkinson's disease. Many people with Parkinson's have levodopa-induced dyskinesias, and these can be troublesome and impact their quality of life," said
The randomized, double-blind, placebo-controlled EASE LID study met its pre-specified primary endpoint demonstrating that patients who received ADS-5102 experienced a significantly greater decrease in LID at 12 weeks than those who received placebo (p=0.0009), as measured by the Unified Dyskinesia Rating Scale (UDysRS). This improvement was maintained at 24 weeks, with ADS-5102-treated patients again showing a significantly greater decrease than placebo-treated patients (p=0.0008). Additionally, the ADS-5102 group
experienced significant improvements in key pre-specified, hierarchical secondary endpoints compared with the placebo group, as measured using the Parkinson's disease home diary. ADS-5102 treatment resulted in a statistically significant increase in ON time without troublesome dyskinesia and a statistically significant decrease in OFF time at 12 and 24 weeks. Adverse events (AEs) were reported for 89 percent of ADS-5102 patients and 60 percent of placebo patients, and most reported were mild to moderate. The most common AEs for ADS-5102 versus placebo were visual hallucinations, peripheral edema, and dizziness. No study drug-related serious AEs were reported. A total of 17 patients discontinued study treatment due to an AE (13 patients in the ADS-5102 group vs. four in the placebo group). The EASE LID trial results were previously presented at the 68th
About ADS-5102 and its
ADS-5102 is a high-dose amantadine taken once daily at bedtime. ADS-5102 was designed to control the initial rate of rise in plasma concentration to mitigate the risk of central nervous system adverse events observed shortly after administration. This dosing regimen results in sustained high plasma levels of amantadine during morning and throughout waking hours when dyskinesia occurs, thereby improving the benefit-risk profile of the drug. If approved, ADS-5102 will meet a significant unmet need, as the first and only medicine approved for dyskinesia in people with Parkinson's disease.
Phase 3 ADS-5102 levodopa-induced dyskinesia clinical program was conducted at movement disorder centers across
The Phase 3 EASE LID 2 long-term, open-label, safety and efficacy study of ADS-5102 is ongoing. Data were recently presented at the 21st
Additionally, patients previously treated with amantadine immediate-release who switched to open-label ADS-5102 experienced a three point, statistically significant reduction in MDS-UPDRS Part IV at Week 8 and maintained out to Week 64. These results were comparable to previous placebo-treated patients, and patients who have undergone prior deep brain stimulation treatment.
The safety data are consistent with the previously reported safety profile of ADS-5102 and the known safety profile of amantadine.
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 dyskinesia 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
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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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