Adamas Announces New Safety and Efficacy Data for GOCOVRI® in Parkinson’s Disease Patients with Dyskinesia at the Movement...
September 20 2019 - 8:00AM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated
pharmaceutical company pioneering time-dependent medicines for
central nervous system (CNS) disorders, announced today the
presentation of new data on GOCOVRI® (amantadine) extended release
capsules for the treatment of dyskinesia in patients with
Parkinson's disease receiving levodopa-based therapy at the
Movement Disorder Society (MDS) 2019 International Congress,
September 22-26, 2019 in Nice, France. The poster presentations
will highlight data derived from the GOCOVRI development program
and post-marketing pharmacovigilance surveillance.
“Adamas’ purpose is to significantly improve the lives of people
affected by neurological diseases, and we remain committed to the
presentation of GOCOVRI data to provide further information to
support robust clinical discussions,” said Rajiv Patni, MD, Chief
Medical Officer at Adamas. “Our goal is to ensure that neurologists
understand how GOCOVRI may be an option for their Parkinson’s
disease patients with dyskinesia on dopaminergic therapies by
providing them with a treatment that may increase functional ON
time by decreasing both dyskinesia and OFF.”
The five posters will be part of the “Clinical Trials,
Pharmacology and Treatment” session on Monday, September 23, 2019,
from 1:45-3:15pm Central European Time (CET). Details of the poster
presentations are as follows:
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Poster 106:
“The Effect of GOCOVRI on Motor Aspects of Experiences of Daily
Living: Analyses of MDS-UPDRS Part II Data from a Phase 3
Program”Lead Author: Dr. Robert Hauser, University of South
Florida |
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Poster 107: “Analysis of the Shape of the GOCOVRI Steady-state
PK Profile: Implications for an Extended Release Product”Lead
Author: Dr. Robert Hauser, University of South Florida |
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Poster 115: “GOCOVRI Dose Adjustment in Elderly Parkinson’s
Patients at Risk for Renal Impairment: Implications from an
Exposure Simulation Model”Lead Author: Dr. Stuart Isaacson,
Parkinson's Disease & Movement Disorders Center of Boca
Raton |
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Poster 171: “The Efficacy and Safety of GOCOVRI Based on Age:
Special Population Analyses of a Phase 3 Study Program”Lead Author:
Dr. Rajesh Pahwa, University of Kansas Medical Center |
|
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Poster 213: “Safety of GOCOVRI in Clinical Practice: One-Year
Post-Launch Pharmacovigilance Data”Lead Author: Dr. Caroline
Tanner, University of California, San Francisco |
About Parkinson’s Disease, OFF and
Dyskinesia
Parkinson’s Disease (PD) is a progressive, neurodegenerative
disorder caused by a dysregulation of neurotransmitter signaling,
afflicting approximately one million people in the United States.
The gradual loss of brain cells producing the neurotransmitter
dopamine leads to this dysregulation, which results in motor
(movement related) and non-motor symptoms. The primary PD treatment
approach is with levodopa, a dopamine precursor, that works by
entering the brain and being converted to dopamine. While this
replacement of dopamine is initially highly effective in relieving
motor symptoms, over time, many patients develop a fluctuating, and
unpredictable response to levodopa. At low dopamine levels,
patients experience stiffness and rigidity, referred to as “OFF”
periods, while at high dopamine levels they experience involuntary
movements known as dyskinesia. The abrupt and unpredictable
transitions between episodes of OFF, dyskinesia and normal movement
lead to considerable disruption of patients’ lives. At this stage
of the disease since the motor symptoms and underlying glutamate
hyperactivity are thought to follow a diurnal pattern across the
waking day of patients, a therapy that effectively attenuates
glutamate hyperactivity using a time-dependent approach, may help
improve good motor control throughout the waking day in individuals
with dyskinesia and OFF.
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 proven to reduce both dyskinesia and OFF.
GOCOVRI is thought to work by reducing the amount of glutamate
hyperactivity in a region of the brain that controls movement, in
patients experiencing dyskinesia and OFF. The NMDA receptor is
activated by glutamate and causes post-synaptic nerve signaling in
this area of the brain, which is modulated by dopamine.
Levodopa therapy replaces dopamine lost in Parkinson’s disease but
may result in large fluctuations in synaptic levels of dopamine
during waking hours, further exacerbating glutamate hyperactivity.
GOCOVRI, developed by Adamas, is novel in that it selectively
blocks the NMDA receptor in a time-dependent manner. Taken at
bedtime, GOCOVRI provides an initial lag and a slow rise in
amantadine concentration during the night and a high concentration
from the morning and throughout the waking day. Additionally, the
adjunctive use of GOCOVRI does 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 see the U.S. Prescribing
Information at www.GOCOVRI.com.
About Adamas Pharmaceuticals, Inc. Adamas’
goal is to create and commercialize a new generation of medicines
intended to lessen the burden of chronic neurologic diseases on
patients, caregivers and society using its deep understanding of
time-dependent biology. The Company is focused on the
commercialization of GOCOVRI™ (amantadine) extended release
capsules, the first and only FDA-approved medicine for the
treatment of dyskinesia in patients with Parkinson’s disease
receiving levodopa-based therapy, with or without concomitant
dopaminergic medications. The Company also continues to deliver
differentiated investigational programs, including ADS-5102 in
development for the treatment of walking impairment in patients
with multiple sclerosis. For more information about Adamas and its
unique approach to developing medicines based on time-dependent
biology, please visit www.adamaspharma.com.
Important Safety Information
Before taking GOCOVRI, patients should tell their doctor
about all medical conditions, including if they:
- have kidney problems; unexpected sleepiness; take medicine to
help them sleep or that makes them drowsy; have mental problems,
such as suicidal thoughts, depression, or hallucinations; unusual
urges including gambling, increased sex drive, compulsive eating,
or shopping; or if they drink alcoholic beverages.
- are pregnant or plan to become pregnant or are breastfeeding or
plan to breastfeed. GOCOVRI may harm the unborn baby and can pass
into breastmilk.
Patients should tell their doctor about all the
medicines they take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements, especially if medicines like sodium
bicarbonate are taken.
What should patients avoid while taking GOCOVRI?
Patients should NOT:
- Take GOCOVRI if they have severe kidney problems.
- Drive, operate machinery, or do other dangerous activities
until they know how GOCOVRI affects them.
- Drink alcohol while taking GOCOVRI as it can increase their
chances of serious side effects.
- Stop or change the dose of GOCOVRI before talking with their
doctor.
- Take a flu nasal spray vaccine while taking GOCOVRI, but they
can receive a flu shot.
What are the possible side effects of
GOCOVRI?
GOCOVRI may cause serious side effects, including:
- falling asleep during normal activities, such
as driving, talking, or eating, while taking GOCOVRI. Patients may
fall asleep without being drowsy or warning.
- suicidal thoughts or actions and
depression.
- occurrence or worsening of hallucinations
(seeing or hearing things that are not real).
- feeling dizzy, faint or light headed,
especially when standing up too quickly, when first starting
GOCOVRI, or if a patient’s dose has been increased.
- unusual urges including gambling, sexual,
spending money, binge eating, and the inability to control
them.
If a patient or their family notices that they are
developing any new, unusual or sudden changes in behavior or
related symptoms, inform the patient’s healthcare provider right
away.
The most common side effects of GOCOVRI include
dry mouth, swelling of legs and feet, constipation, and falls.
For additional important safety information, please see
GOCOVRI full Prescribing Information at
www.gocovri.com.
Contacts: Investors: Peter Vozzo Westwicke
Partners 443-213-0505 Peter.vozzo@westwicke.com
Media: Sarah Mathieson Vice President, Communications and
EngagementAdamas Pharmaceuticals, Inc. 510-450-3528
smathieson@adamaspharma.com
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