- GOCOVRI is now the first and only medication
approved to treat OFF and dyskinesia motor complications -
- Adamas to host webcast conference call today
at 4:30 pm ET/1:30 pm PT -
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 it has received marketing authorization from the U.S.
Food and Drug Administration (FDA) for a supplemental New Drug
Application for GOCOVRI® (amantadine) extended release capsules,
gaining a second indication for the product. GOCOVRI is now
approved as an adjunctive treatment to levodopa/carbidopa in
patients with Parkinson’s disease experiencing OFF episodes, in
addition to its indication for the treatment of dyskinesia in
patients with Parkinson’s disease receiving levodopa-based therapy,
with or without concomitant dopaminergic medications.
“The approval of a second indication for GOCOVRI is a major
milestone for patients with Parkinson’s who experience motor
complications in their daily lives. GOCOVRI is now the first and
only medication approved to treat both OFF and dyskinesia motor
complications in Parkinson’s disease,” said Neil F. McFarlane,
Chief Executive Officer. “This approval also meaningfully enhances
our commercial opportunity by more than doubling the potential
number of patients with conditions GOCOVRI is approved to treat. I
am very pleased with the performance of our team in executing our
growth strategy and look forward to improving access for patients
in 2021 and beyond with the expanded label for GOCOVRI.”
Data from two pivotal, placebo-controlled Phase 3 clinical
studies showed that treatment with GOCOVRI significantly reduced
both OFF time and dyskinesia. This resulted in a clinically
meaningful increase in good ON time in patients taking a
levodopa-based medication for Parkinson’s disease. Additionally,
GOCOVRI demonstrated sustained efficacy for at least two years in
the Phase 3, open-label EASE LID-2 study.
“We are delighted in the FDA’s responsiveness to our application
to include the clinically meaningful reduction in OFF episodes in
the indication statement which provides patients and physicians
with accurate and complete information to make appropriate
treatment decisions,” said Adrian Quartel, M.D., Chief Medical
Officer. “The extensive clinical trial evidence for GOCOVRI
supports its unique ability to reduce OFF episodes and dyskinesia
in people with Parkinson’s disease who are on levodopa/carbidopa
therapy. Many PD medications necessitate a trade-off between
reducing OFF time and exacerbating levodopa-induced dyskinesia.
GOCOVRI is the first medication approved to reduce both.”
Conference call details
Adamas will host a conference call and webcast today, February
1, 2021, at 4:30 pm ET/1:30 pm PT to discuss the approval of its
sNDA for GOCOVRI. The conference call can be accessed by dialing
(877) 407-9716 (toll-free) or 201-493-6779 (toll/international)
using the conference ID 13715919. The webcast can be accessed live
via the Investors section of the Adamas website at
http://ir.adamaspharma.com/events-presentations and will be
available for replay for approximately 30 days.
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 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 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.
Forward-looking statements
Statements 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 regarding the
potential number of patients with conditions GOCOVRI is approved to
treat. 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 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 5, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210201005801/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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