Navigation Links
Adamas Pharmaceuticals To Report Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Parkinson's Disease
Date:6/10/2013

EMERYVILLE, Calif., June 10, 2013 /PRNewswire/ -- 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.

1) Encarnacion, 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.
2) DATATOP: A Multicenter Controlled Clinical Trial in Early Parkinson's Disease. Archives of Neurology, 1989. 46(10): p. 1052-60
3) The Michael J. Fox Foundation (www.michaeljfox.org)


'/>"/>
SOURCE Adamas Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
2. Access Pharmaceuticals Signs US License Agreement With AMAG Pharmaceuticals For MuGard
3. HemaQuest Pharmaceuticals Completes Patient Enrollment in Phase 2b Clinical Study of HQK-1001 in Patients with Sickle Cell Disease
4. Oramed Pharmaceuticals to Present at IATI-BioMed Conference in Israel
5. DelMar Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
6. Valeant Pharmaceuticals Announces Filing Of Preliminary Base Shelf Prospectus
7. Ampio Pharmaceuticals Issues Statement Regarding Misleading Blog
8. Actinium Pharmaceuticals, Inc. Receives $3.5m from Exercise of Warrants
9. Piramal Imaging Highlights New Data for Florbetaben and Other Investigational Radiopharmaceuticals at SNMMI 2013
10. Ampio Pharmaceuticals to List on the NYSE MKT
11. Isis Pharmaceuticals Earns $6 Million Payment from AstraZeneca
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)...  Collagen Matrix, Inc., ("Collagen Matrix") the driving ... collagen and mineral based medical devices for tissue ... Messer has joined the company as Vice ... growing portfolio of oral surgery, neurosurgery, orthopaedic and ... the Collagen Matrix executive team as an accomplished ...
(Date:6/24/2016)... 2016 Dublin ... addition of the " Global Markets for Spectroscopy ... This report focuses on the ... review, including its applications in various applications. The report ... includes three main industries: pharmaceutical and biotechnology, food and ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution ... the emergency ambulance transport experience for the millions of people who require these ... disrupted the taxi industry through the use of technology. Now, SmartEMS has put ...
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June ... , brings up a new, often overlooked aspect of head lice: the parasite’s ability to ... is not a common occurrence, but a necessary one in the event that lice have ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her ... would lash out at his family verbally and physically. , “When something upset him, he ... he would use it. He would throw rocks at my other children and say he ...
Breaking Medicine News(10 mins):