Adamas Pharmaceuticals To Report Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Parkinson's Disease
Emeryville, Calif., June 10, 2013 - Adamas Pharmaceuticals, Inc. announced today that the Company’s Phase 2/3 EASED™ (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia) clinical trial of ADS-5102 (Nurelin™; amantadine HCl extended release) met the study's primary endpoint. ADS-5102 is an investigational extended-release formulation of amantadine intended for once-nightly administration that is being evaluated for the treatment of levodopa-induced dyskinesia (LID) in Parkinson’s disease (PD) patients.
"I am pleased to report our Phase 2/3 EASED study of ADS-5102 for the treatment of LID in Parkinson's disease met the study's primary endpoint with statistical significance," said Gregory T. Went, Ph.D., Chief Executive Officer of Adamas. "We look forward to sharing the clinical results from the EASED trial of ADS-5102 at the upcoming International Congress of Parkinson's Disease and Movement Disorders."
Data from the Phase 2/3 EASED clinical study of ADS-5102 have been accepted for presentation at the 17th International Congress of Parkinson's Disease and Movement Disorders taking place on June 16-20, 2013 in Sydney, Australia. Rajesh Pahwa, M.D., Professor of Neurology, University of Kansas Medical Center and an investigator for the EASED study will present the final results during the "Parkinson's Disease: Clinical Trials" session in a poster entitled Randomized Trial of Extended Release Amantadine in Parkinson's Disease Patients with Levodopa−induced Dyskinesia (EASED Study) (abstract #443) on June 18, 2013 at 12:30 pm AEST.
About the EASED Study
The EASED study was a randomized, double-blind, placebo-controlled clinical trial that enrolled 83 Parkinson's disease subjects at 31 study sites in the US (NCT 01397422). The study's primary efficacy analysis compared ADS-5102 to placebo for reduction in LID over 8 weeks as assessed by the Unified Dyskinesia Rating Scale (UDysRS). Secondary efficacy outcome measures included changes in a standardized PD diary, including "ON time" without troublesome dyskinesia; overall PD clinical status as assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS); and fatigue measured using the Fatigue Severity Scale. The EASED trial also included an assessment of dose response for ADS-5102. The study enrolled male and female subjects aged 30 to 85 years who had Parkinson's disease and were experiencing troublesome LID. Study participants were randomized to receive a low, medium or high dose of ADS-5102 or placebo once-nightly for eight weeks with a two-week safety follow-up. Safety measures included adverse events and routine safety laboratory tests that were reviewed during the study by an independent data monitoring committee. Additional information about the study will be presented in the poster.
About ADS-5102 (Nurelin™)
ADS-5102 is a proprietary, investigational, extended-release formulation of amantadine HCl in development for the treatment of central nervous system (CNS) disorders, including LID in Parkinson's disease. Designed for once-nightly administration, ADS-5102's unique “chronotherapeutic” profile is characterized by a slow increase in amantadine plasma concentrations, expected to result in high plasma concentrations during the daytime hours when LID can be troublesome, and low plasma concentrations overnight. The low overnight amantadine plasma concentration may reduce the insomnia, sleep disturbances, and vivid dreams occasionally associated with amantadine. Due to its altered pharmacokinetic profile, ADS-5102 is being investigated in clinical studies at daily dose strengths greater than those typically used with immediate-release amantadine.
About Levodopa-Induced Dyskinesia
Levodopa (also known as L-dopa) remains the gold standard for the treatment of the debilitating motor symptoms of Parkinson's disease. An unfortunate side effect of prolonged treatment with levodopa is the occurrence of levodopa-induced dyskinesia (LID). LID is characterized by involuntary non-purposeful movements of the head and neck, arms, legs or trunk. With continued levodopa treatment, and as PD progresses, LID can become severely disabling and has been associated with a decrease in the quality of life for Parkinson's patients.1 LID affects approximately 30% of patients taking levodopa2, and is particularly problematic among young-onset Parkinson's disease patients. There are currently no medications approved for the treatment of LID. Reducing LID and improving “on time” without troublesome dyskinesia are among the greatest patient unmet medical needs in the treatment of advanced Parkinson's disease.3
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals is dedicated to improving the lives of those affected by central nervous system (CNS) disorders by optimizing the pharmacokinetic profiles of approved drugs to create novel treatments for use alone and as components of fixed-dose combination products. The Company is currently advancing a pipeline of aminoadamantane-based drug candidates for the treatment of Parkinson's disease, Alzheimer's disease, and other CNS disorders. The Phase 2/3 EASED study investigating ADS-5102 (amantadine HCl extended release) for the treatment of levodopa-induced dyskinesia in Parkinson's disease has recently been completed. MDX-8704 (memantine HCl ER/donepezil, US) and ADS-8704 (memantine HCl ER/donepezil, ex-US) are fixed-dose combination products in late-stage investigation for the treatment of dementia associated with Alzheimer's disease. In November 2012, Adamas entered into an agreement with Forest Laboratories, Inc. for the development and commercialization of MDX-8704 in the United States. Adamas plans to advance its product candidates through approval and commercialize products in the United States through a specialty CNS sales force. For more information about Adamas, please visit www.adamaspharma.com.
1Encarnacion, E. V., Hauser, R. A., "Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments." Eur Neurol , 2008. 60(2): 57-66.
2DATATOP: A Multicenter Controlled Clinical Trial in Early Parkinson's Disease. Archives of Neurology, 1989. 46(10): p. 1052-60
3The Michael J. Fox Foundation (www.michaeljfox.org)
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