Adamas Announces Data Presentation on ADS-5102 at the Academy of Managed Care Pharmacy 2017 Annual Meeting
March 28 2017 - 12:39PM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details
regarding a poster presentation highlighting data from EASE LID,
its Phase 3 efficacy study of ADS-5102 (amantadine hydrochloride)
extended-release capsules for the treatment of levodopa-induced
dyskinesia (LID) in patients with Parkinson’s disease, to be
presented at the Academy of Managed Care Pharmacy’s (AMCP) 2017
Annual Meeting held in Denver, Colorado, March 27 – 30, 2017. The
poster will be available for review at an author session on March
28, from 5:45p.m. – 7:30p.m. MDT, and for general review on March
29, from 11:45a.m. – 2:45p.m. MDT.
Poster Presentation Details
Title: |
ADS-5102 (amantadine
hydrochloride) Extended-Release Capsules Improve Clinician’s Global
Impression of Change (CGI-C) and Activities of Daily Living (ADL)
by Reducing Levodopa-Induced Dyskinesia (LID) in Parkinson’s
Disease (EASE LID Study) |
Abstract and Poster
Number: |
G10 |
Author Hour Poster
Session Date: |
Tuesday, March 28 |
Author Hour Poster
Session Time: |
5:45p.m. – 7:30p.m.
MDT |
Poster Session
Date: |
Wednesday, March
29 |
Poster Session
Time: |
11:45a.m. – 2:45p.m.
MDT |
Room: |
Colorado Convention
Center Hall DE |
About the EASE LID StudyThe
Phase 3 EASE LID study was a multi-center, randomized,
double-blind, placebo-controlled study designed to evaluate the
safety and efficacy of 340 mg of ADS-5102 dosed once daily at
bedtime for 24 weeks in patients with LID associated with
Parkinson’s disease. The study's primary efficacy analysis measured
the reduction in LID over 12 weeks as assessed by the Unified
Dyskinesia Rating Scale (UDysRS). The key secondary efficacy
outcome measures were a reduction in LID over 24 weeks as assessed
by the UDysRS and changes in a standardized Parkinson’s Disease
home diary, including ON time without troublesome dyskinesia and
OFF time at weeks 12 and 24. Additional secondary efficacy outcome
measures included overall Parkinson’s Disease clinical status as
assessed by the Movement Disorder Society-Unified Parkinson's
Disease Rating Scale (MDS-UPDRS) and the Clinician's Global
Impression of Change (CGI-C).
About ADS-5102 ADS-5102 is a chrono-synchronous
amantadine therapy with potential applications across several
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. Parkinson's disease 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. Levodopa is the most effective therapy for
all stages of Parkinson's disease and is considered the "gold
standard" therapy. As a result of the disease progression and
chronic levodopa therapy, nearly all Parkinson's disease patients
will experience LID depending on their levodopa dose. LID is
characterized by involuntary movements that are non-rhythmic,
purposeless and unpredictable.
About Adamas Pharmaceuticals,
Inc.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,
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.
Contact:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3528
ir@adamaspharma.com
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From Apr 2024 to May 2024
Adamas Pharmaceuticals (NASDAQ:ADMS)
Historical Stock Chart
From May 2023 to May 2024