Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) a company dedicated to
developing and delivering medicines that make a clinically
meaningful difference for people affected by neurological diseases,
today announced the publication of final results from a two-year
open-label study in Parkinson’s disease (PD) that demonstrated a
sustained improvement in levodopa-induced dyskinesia (LID) among
patients using GOCOVRI® (amantadine) extended-release capsules.
The trial enrolled 223 patients, and results
demonstrated that the treatment effect of GOCOVRI on motor
complications (dyskinesia and OFF), as measured by the Movement
Disorder Society‐Unified Parkinson’s Disease Rating Scale
(MDS‐UPDRS), Part IV, was maintained for at least two years. This
effect was seen in all subgroups, including those who continued
treatment from prior double-blind trials, from placebo or
amantadine immediate release (IR), as well as a subgroup of
patients with dyskinesia receiving deep brain stimulation (DBS)
treatment.
Published online in the Journal of Parkinson’s
Disease, the new paper titled “EASE LID 2: A 2-year open-label
trial of GOCOVRI (amantadine) extended release for dyskinesia in
Parkinson’s disease,” shares results from the 223-participant study
(mean PD duration, 11.7 years; mean levodopa use, 9.3 years). The
EASE LID 2 study was designed to reflect real-world treatment
conditions by including patients with DBS implants and those
switching from amantadine IR, while also allowing study physicians
to adjust patient’s other PD medications as needed during the
study.
“As the longest-running amantadine study to date, this
open-label trial suggests GOCOVRI may provide sustained improvement
in both dyskinesia and OFF to a wide cohort of patients with
Parkinson’s disease living with motor complications,” said Dr.
Caroline Tanner, Professor, Dept. of Neurology at University of
California, San Francisco. “These results expand not only our
knowledge of GOCOVRI efficacy but also of its long-term safety in
these patients.”
“These newly published results suggest that
GOCOVRI may reduce dyskinesia and OFF as far out as 100 weeks,
providing sustained benefits to patients with levodopa-induced
dyskinesia. Given the chronic nature of Parkinson’s disease, both
patients and physicians seek treatments that are effective
long-term,” said Jean Hubble, MD, Vice President of Medical Affairs
for Adamas. “This study further demonstrates that the only
FDA-approved medicine for dyskinesia may help people with PD who
are struggling to manage these levodopa-related motor complications
over this long period of time.”
Overall the median treatment duration for trial participants was
1.9 years. In total, 13.9% discontinued the study because of
adverse events considered to be related to GOCOVRI. All patients
who received at least one dose of GOCOVRI were included in the
safety analyses, which demonstrated findings broadly consistent
with the phase III trials and product labeling. Common adverse
events were falls, hallucinations, peripheral edemas, constipation
and urinary tract infections.
Reference:Full open access
study: “EASE LID 2: A 2-Year Open-Label Trial of Gocovri
(Amantadine) Extended Release for Dyskinesia in Parkinson’s
Disease”Published in the Journal of Parkinson’s Disease, online in
pre-press mode ahead of publication of the issue.
Link:
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd191841
DOI: 10.3233/JPD-191841
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.
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 Pharmaceuticals,
Inc.
At Adamas, our purpose and vision are clear:
deliver innovative medicines that make a clinically meaningful
difference for patients, caregivers and society. We are a
fully-integrated company focused on growing a portfolio of
therapies that address a range of neurological diseases. For more
information, please visit www.adamaspharma.com.
Forward-looking statements
Statements 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 November 7, 2019, 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:
Investors:Peter VozzoManaging Director,
Westwicke443-213-0505peter.vozzo@westwicke.com
Media:Sarah MathiesonVice President of Corporate
Communications510-450-3528smathieson@adamaspharma.com
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