Adamas Pharma Presents Additional Open-Label, Long-Term Safety And Efficacy Data On ADS-5102 At The First Pan American Parkinson’s Disease And Movement Disorders Congress
EMERYVILLE, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the presentation of additional data from EASE LID 2, its Phase 3 open-label, long-term safety and efficacy study of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease, at the first Pan American Parkinson’s Disease and Movement Disorders Congress. The updated analysis demonstrates the safety and tolerability of ADS-5102 and a reduction in LID and OFF time symptoms for up to 64 weeks. Symptoms of LID are 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.
“This additional open-label data further supports the long-term safety and efficacy of ADS-5102,” said Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology and Director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas Medical Center. “It is noteworthy that an approximate five unit reduction in the mean MDS-UPDRS, Part IV score, from a baseline score of approximately 12 units, has now been maintained from Week 2 up to Week 64 for patients in this study. Sustained duration of effect on LID and OFF time increasingly suggests the long-term durability of ADS-5102 for the treatment of LID in patients with Parkinson’s disease, as only 5 percent of the patients who previously received ADS-5102 discontinued from this open-label study due to an adverse event.”
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.
About ADS-5102
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 FDA, with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017. If approved, ADS-5102 will be the first and only FDA-approved medicine for the treatment of LID in patients with Parkinson’s disease. Adamas is also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis patients and is considering developing it for other indications in Parkinson’s disease earlier in the treatment journey.
About Parkinson's disease and Levodopa-induced Dyskinesia
Parkinson’s disease is a chronic neurodegenerative disorder affecting close to 1 million people in the United States. It is characterized by the progressive loss of dopaminergic neurons, causing lower levels of endogenous dopamine and manifesting as symptoms of bradykinesia (slowness of movement), rigidity, impaired walking, tremor and postural instability. As a replacement therapy for the loss of dopaminergic neurons, levodopa is the most effective therapy for Parkinson’s disease and is considered the “gold standard.” As a result of disease progression and chronic levodopa therapy, nearly all Parkinson’s disease patients will experience levodopa-induced dyskinesia (LID) depending on their levodopa dose. LID is characterized by involuntary movements that are non-rhythmic, purposeless, and unpredictable. In the U.S., approximately 150,000 to 200,000 Parkinson’s patients suffer from LID at any given time, and over time, 90 percent of patients on levodopa therapy will develop it.i Currently, there is no FDA-approved medicine for the treatment of LID in patients with Parkinson’s disease.
About Adamas Pharmaceuticals, Inc.
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 FDA, with a PDUFA date of August 24, 2017. Adamas is exploring other indications for ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas’ licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan, and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectively. For more information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz Pharma GmbH & Co. KGaA.
Forward-looking Statements
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 Securities and Exchange Commission on November 3, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.
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i Ahlskog JE, Muenter MD. Mov Disord. 2001
Contact: Martin Forrest Vice President, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. 510-450-3528