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 its presentation of a new post-hoc pivotal trial data
analysis at the American Academy of Neurology (AAN) Science
Highlights Platform showing GOCOVRI decreasing dyskinesia and OFF
time for people with Parkinson’s Disease (PD) using GOCOVRI®
(amantadine) extended release capsules. GOCOVRI is indicated for
the treatment of dyskinesia in people with Parkinson's disease
receiving levodopa-based therapy. The abstract and poster
presentation are available on the 2020 AAN Science Highlights
Platform.
In this pooled retrospective data analysis, the
subset of patients who experienced more than 2.5 hours of OFF time
and at least an hour of troublesome dyskinesia a day (101 patients
out of total 198 enrolled in clinical trials) were evaluated which
showed an improvement of 3.4 hours per day in good ON time on
GOCOVRI, compared to placebo. This improvement in good ON time was
due to a reduction in the number of hours spent in OFF as well as
the hours spent ON with troublesome dyskinesia. In addition to
increasing good ON time, patient-reported assessments showed
GOCOVRI demonstrated significant improvements in the impact of
their symptoms on daily activities and provided more continuous ON
time without interruptions from OFF and dyskinesia episodes.
“This presentation aims to provide additional
insights on the effect of GOCOVRI in reducing OFF time for patients
with Parkinson’s disease,” said Robert A. Hauser MD, MBA, Professor
of Neurology, Director, USF Parkinson’s Disease and Movement
Disorders Center Parkinson Foundation Center of Excellence, and
lead author of the presentation. “For clinicians seeking to improve
management of OFF and dyskinesia for patients without adjusting
levodopa doses, these results suggest GOCOVRI could be an important
treatment option.”
“It is our hope at Adamas that patients will not
have to make the difficult decision between reducing OFF time or
troublesome dyskinesia,” said Jean Hubble MD, Vice President,
Medical Affairs at Adamas. “I am encouraged these results show
GOCOVRI can lead to increased good ON time, giving patients the
opportunity to spend time with family and friends with fewer
disruptions and more sustained good ON time.”
The reduction of OFF was measured as a secondary
outcome in the Phase 3 trials for GOCOVRI. Recent OFF trials
typically require participants to experience 2-3 hours a day of OFF
time at baseline, therefore the subset of patients in this post-hoc
study evaluated those who had at least 2.5 hours of OFF time a
day.
Presentation details are as follows:
Title: GOCOVRI reduces
disruptive motor episodes and improves function in Parkinson’s
disease patients with OFF episodes and dyskinesia: Analysis of
phase 3 trial data Lead Author: Robert A. Hauser,
MD, MBA, Professor of Neurology, Director, USF Parkinson’s Disease
and Movement Disorders Center, Parkinson Foundation Center of
Excellence.Poster: 3387
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, including the
expectations as to the long-term benefits of GOCOVRI, are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. 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’
commercial activities relating to GOCOVRI, 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 May 7, 2020, particularly under the caption
“Risk Factors.” 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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