Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, announced
today two presentations on GOCOVRI® (amantadine) extended release
capsules (ADS-5102) for the treatment of dyskinesia in patients
with Parkinson's disease receiving levodopa-based therapy at the
Movement Disorder Society (MDS) 2020 Virtual Congress, September
12-16, 2020.
“These presentations provide further evidence
that GOCOVRI may reduce OFF time for people with Parkinson’s, with
prolonged effects for at least two years,” said Jean Hubble MD,
Vice President, Medical Affairs at Adamas. “Both dyskinesia and OFF
disrupt daily activities for people with PD and treating dyskinesia
should not come at the expense of increased OFF, or vice versa. For
patients who seek good ON time with long-term reductions in
dyskinesia and OFF, providers can consider GOCOVRI as a treatment
option shown to provide substantial and sustained benefits.”
The following posters will be available in the MDS 2020 Virtual
Poster Hall beginning September 11, 2020:
Poster #896: Among Parkinson’s disease patients
with both OFF and dyskinesia, ADS-5102 (amantadine)
extended-release reduces disruptive motor episodes and improves
function: Analysis of phase 3 trialsLead Author:
Robert A. Hauser, MD, MBA, USF Parkinson’s Disease and Movement
Disorders Center, Parkinson Foundation Center of Excellence.
Poster #955: Long-term effects of ADS-5102
(amantadine) extended release capsules on OFF symptoms in
Parkinson’s disease patients with levodopa-induced dyskinesia:
Analysis of EASE LID 2 trialLead Author: Caroline
M. Tanner, MD, PhD, University of California San Francisco.
About Parkinson’s Disease, Dyskinesia,
and OFFParkinson’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 are likely to experience unpredictable
stiffness, rigidity, and tremors, referred to as OFF time. 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 time 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. It is also the only medicine clinically
proven to reduce both dyskinesia and OFF. Taken once daily at
bedtime, GOCOVRI provides an initial lag and a slow rise in
amantadine concentration during the night, resulting in a high
concentration from the morning and throughout the waking day.
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 AdamasAt 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.
Forward-looking statementsStatements contained
in this press release regarding matters that may occur in the
future are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not
limited to, statements contained in this press release regarding
Adamas’ expectations of its full year 2020 expenses. Such
statements are subject to risks and uncertainties, and 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, development and commercial
activities relating to GOCOVRI and ADS-5102, and the regulatory and
competitive environment and Adamas’ business in general, see
Adamas’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 6, 2020, particularly under the
caption “Risk Factors.” In addition, the impact that the current
COVID-19 pandemic is having and will have on demand for GOCOVRI,
and the unknown duration and severity of the COVID-19 pandemic, add
additional risk and uncertainty to these forward-looking
statements. 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, except as required
by law.
Contact:
Media:Sarah MathiesonVice President of Corporate
Communications510-450-3528smathieson@adamaspharma.com
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Investors:Peter VozzoManaging Director,
Westwicke443-213-0505peter.vozzo@westwicke.com
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