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 the publication of a new data analysis titled, “Effects
of GOCOVRI® (amantadine) extended-release capsules on motor aspects
of experiences of daily living in people with Parkinson’s disease
and dyskinesia” in the peer-reviewed journal of Neurology and
Therapy. The publication highlights a post-hoc data analysis from
two placebo-controlled Phase 3 clinical trials, including a total
of 196 patients. Results from the analysis were driven primarily by
improvements in motor activities important to patients such as
freezing, tremor, and getting out of bed/car/deep chair.
“For people living with Parkinson’s disease, motor complications
often have a broad impact on daily activities,” said Robert A.
Hauser, M.D., M.B.A., Professor of Neurology and Director of the
Parkinson’s Disease and Movement Disorders Center at the University
of South Florida. “The improvements in patient-perceived disability
associated with motor aspects of PD -- such as freezing of gait,
tremors, and getting out of bed -- support the use of GOCOVRI as an
important treatment option for PD motor complications.”
“This analysis suggests that GOCOVRI may meaningfully reduce the
impact of PD motor symptoms on experiences of daily living,” said
Adrian Quartel, Chief Medical Officer, Adamas. “The suggestion that
GOCOVRI may impact gait freezing is a particularly interesting
finding because freezing appears to be separate from the disease’s
primary motor symptoms and is a noted unmet need in the treatment
of Parkinson’s.”
In two randomized Phase 3 trials (EASE LID and EASE LID 3),
GOCOVRI or placebo was administered for at least 12 weeks to a
total of 196 people with Parkinson’s, and the treatment impact of
GOCOVRI on dyskinesia was assessed using the Unified Dyskinesia
Rating Scale (UDysRS). In this post-hoc analysis, the treatment
impact of GOCOVRI on patient-reported motor experiences of daily
living was assessed using Part II of the Movement Disorder Society
Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
At week 12, participants treated with GOCOVRI reported
statistically significant improvements in motor control for daily
activities compared to placebo (least-squares mean changes from
baseline of –3.4 points for GOCOVRI and –1.4 for placebo). The
overall treatment difference with GOCOVRI was driven primarily by
statistically significant improvements in items related to
freezing, tremor, and getting out of bed/car/deep chair. For
patients who reported at least mild scores (≥2, problematic) for
freezing of gait at baseline, 53.8% taking GOCOVRI and 17.1% taking
placebo improved to a nonproblematic score of 0 (none) or 1
(slight) at week 12. For those reporting at least a mild score for
tremors at baseline, 66.7% taking GOCOVRI and 35.9% taking placebo
improved to a nonproblematic score at week 12. Limitations of this
exploratory analysis include the post-hoc nature of the component
analysis and insufficient presence of disability for several items
at baseline that may affect the ability to show response.
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, referred to as OFF episodes between
medication doses, that 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/20210610005080/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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