Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated
to developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, today
announced two posters will be presented at the American Academy of
Neurology (AAN) 73rd Annual Meeting. One of the presentations will
focus on GOCOVRI® (amantadine) extended-release capsules, the first
and only FDA-approved medicine indicated for the treatment of
dyskinesia in patients with Parkinson’s disease receiving
levodopa-based therapy, with or without concomitant dopaminergic
medications, and as an adjunctive treatment to levodopa/carbidopa
in patients with Parkinson’s disease experiencing OFF episodes. The
second presentation will feature a survey exploring the impact of
dyskinesia and OFF time in people living with PD.
“Data presented at this year’s AAN Annual Meeting highlight the
widespread prevalence of motor complications and associated
negative social and emotional impacts on people with Parkinson’s
and their care partners and also supports GOCOVRI’s unique clinical
profile to treat both OFF and dyskinesia motor complications in
Parkinson’s disease,” said Adrian Quartel, M.D., Chief Medical
Officer. “We will present new data analyses of our pivotal trials
evaluating the treatment impact of GOCOVRI in increasing ON time
without any dyskinesia. As the only medication approved to treat
OFF and dyskinesia, GOCOVRI may be an appropriate treatment option
for people with PD experiencing either end of the spectrum of
levodopa-related motor complications (OFF or dyskinesia) or
both.”
The posters will be available for on-demand viewing the duration
of the virtual meeting, April 17 – 22, 2021 from 7:00 am – 5:00 pm
EDT. Poster details as follows:
GOCOVRI poster
presentation
Title: ADS-5102 significantly increases ON time without
dyskinesia: Pooled patient diary analyses from Parkinson’s disease
pivotal trials Session name: P14: Clinical Trials, Surveys,
and Studies in Movement Disorders Lead author: Robert A.
Hauser, M.D., University of South Florida Program number:
P14.128
Disease state poster
presentation
Title: Evaluating the impact of levodopa-induced
dyskinesia and OFF time in persons affected by Parkinson’s disease:
Results of a PMD Alliance survey Session name: P14: Clinical
Trials, Surveys, and Studies in Movement Disorders Lead
author: Jill Farmer, D.O., M.P.H., Drexel University and the
Global Neurosciences Institute Program number: P14.148
About Parkinson’s disease, OFF and dyskinesia
Parkinson’s disease (PD) is a progressive, neurodegenerative
disorder caused by the gradual loss of brain cells that produce the
neurotransmitter dopamine and affects approximately one million
people in the United States. Dopamine decline in the brain results
in a wide range of motor (movement-related) and non-motor symptoms.
As the disease progresses, people taking levodopa-based therapy are
likely to experience reemergence or sudden return of stiffness,
rigidity and tremors between medication doses, referred to as OFF
episodes, which may be unpredictable. The primary treatment for PD
is with levodopa; however, over time levodopa may lead to
involuntary, uncontrolled movements known as dyskinesia. The abrupt
and unpredictable transitions between episodes of dyskinesia,
normal movement, and OFF lead to considerable impact on patients’
lives.
About GOCOVRI
GOCOVRI® (amantadine) extended-release capsules is the first and
only FDA-approved medicine indicated for the treatment of
dyskinesia in patients with Parkinson’s disease receiving
levodopa-based therapy, with or without concomitant dopaminergic
medications, and as an adjunctive treatment to levodopa/carbidopa
in patients with Parkinson’s disease experiencing OFF episodes.
Taken once daily at bedtime, GOCOVRI provides an initial lag
(delayed release) and a slow rise in amantadine concentration
during the night, resulting in a high concentration from the
morning and throughout the waking day (extended release).
Additionally, in the clinical trials, the adjunctive use of GOCOVRI
did not require dose changes to dopaminergic therapies. The most
commonly observed adverse reactions with GOCOVRI were
hallucinations, dizziness, dry mouth, peripheral edema,
constipation, falls and orthostatic hypotension.
For more information about GOCOVRI, please visit
www.GOCOVRI.com.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GOCOVRI is
contraindicated in patients with creatinine clearance below 15
mL/min/1.73 m2
WARNINGS AND PRECAUTIONS Falling Asleep During Activities of
Daily Living and Somnolence: Patients treated with Parkinson’s
disease medications have reported falling asleep during activities
of daily living. If a patient develops daytime sleepiness during
activities that require full attention (e.g., driving a motor
vehicle, conversations, eating), GOCOVRI should ordinarily be
discontinued or the patient should be advised to avoid potentially
dangerous activities.
Suicidality and Depression: Monitor patients for depression,
including suicidal ideation or behavior. Prescribers should
consider whether the benefits outweigh the risks of treatment with
GOCOVRI in patients with a history of suicidality or
depression.
Hallucinations/Psychotic Behavior: Patients with a major
psychotic disorder should ordinarily not be treated with GOCOVRI
because of the risk of exacerbating psychosis. Observe patients for
the occurrence of hallucinations throughout treatment, especially
at initiation and after dose increases.
Dizziness and Orthostatic Hypotension: Monitor patients for
dizziness and orthostatic hypotension, especially after starting
GOCOVRI or increasing the dose.
Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose
reduction or abrupt discontinuation of GOCOVRI, may cause an
increase in the symptoms of Parkinson’s disease or cause delirium,
agitation, delusions, hallucinations, paranoid reaction, stupor,
anxiety, depression, or slurred speech. Avoid sudden
discontinuation of GOCOVRI.
Impulse Control/Compulsive Behaviors: Patients may experience
urges (e.g. gambling, sexual, money spending, binge eating) and the
inability to control them. It is important for prescribers to ask
patients or their caregivers about the development of new or
increased urges. Consider dose reduction or stopping
medications.
ADVERSE REACTIONS The most common adverse reactions (>10%)
were hallucination, dizziness, dry mouth, peripheral edema,
constipation, fall, and, orthostatic hypotension.
Please see full Prescribing Information for additional important
safety information at
https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.
About Adamas
At Adamas our vision is clear – to deliver innovative medicines
that reduce the burden of neurological diseases on patients,
caregivers and society. We are a fully-integrated company focused
on growing a portfolio of therapies to address a range of
neurological diseases. For more information, please visit
www.adamaspharma.com.
Source: Adamas Pharmaceuticals, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210415005240/en/
Media: Sarah Mathieson Vice President of Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
Investors: Peter Vozzo Managing Director, Westwicke
443-213-0505 peter.vozzo@westwicke.com
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