Adamas Presents New Data Analysis Demonstrating that GOCOVRI™ Reduces Transitions between Dyskinesia and OFF Episodes Throu...
June 22 2018 - 8:12AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the
presentation of new data analysis of GOCOVRI™ (amantadine) extended
release capsules, from the Phase 3 pivotal studies, demonstrating
that the reductions in both dyskinesia and OFF experienced by
GOCOVRI-treated patients results in longer periods of ON time
without troublesome dyskinesia and reduced transitions between
Parkinson’s disease diary states. The analysis will be
presented in an oral poster, entitled ADS-5102 Reduces ON Time with
Troublesome Dyskinesia and OFF Time Throughout the Waking Day-Time
Course Analysis, at the 2nd Annual Pan American Parkinson’s
Diseases and Movement Disorders Congress in Miami, FL.
GOCOVRI is the first and only medicine approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
dyskinesia in people with Parkinson’s disease receiving
levodopa-based therapy, with or without concomitant dopaminergic
medications. It is also the first FDA-approved drug to improve
dyskinesia as well as demonstrate a secondary benefit in reducing
OFF, in these patients.
“The Parkinson’s disease home diary data from the
GOCOVRI Phase 3 pivotal studies clearly show that the entire waking
day may be impacted by troublesome dyskinesia. Of note, troublesome
dyskinesia can happen in the morning after a patient takes the
first dose of levodopa,” said Rajiv Patni, MD, Chief Medical
Officer of Adamas Pharmaceuticals, Inc. “By Week 12,
GOCOVRI-treated patients experienced a decrease in the number of
transitions between these diary states, resulting in longer periods
of uninterrupted ON time without troublesome dyskinesia. The
observation that 17 percent of GOCOVRI-treated patients did not
experience any transitions during the waking day is particularly
noteworthy. This new analysis provides a useful definition of
transitions that reinforces the previously reported data of GOCOVRI
on dyskinesia and OFF.”
During the study, 162 patients (77 treated with
GOCOVRI and 85 with placebo) provided a complete and evaluable
Parkinson’s disease home diary at both baseline and Week 12. At
Week 12, the reductions in both dyskinesia and OFF for
GOCOVRI-treated patients resulted in much longer periods of ON time
without troublesome dyskinesia. GOCOVRI-treated patients, on
average, experienced a 3.2-hour placebo adjusted increase in their
first episode of ON time without troublesome dyskinesia. In
addition, at Week 12, GOCOVRI-treated patients experienced 4.2 less
transitions between diary states a day compared to 2.0 less
transitions for placebo-treated patients. Approximately 17
percent of GOCOVRI-treated patients become transition-free versus
approximately one percent of placebo-treated patients. The safety
data was consistent with the overall population of the pivotal
trials for GOCOVRI. The most common adverse reactions (>10
percent) were hallucination, dizziness, dry mouth, peripheral
edema, constipation, falls, and orthostatic hypotension.
About Parkinson’s Disease and
DyskinesiaIn the United States, there are close to one
million people living with Parkinson’s disease, a chronic
neurodegenerative disorder, and an estimated 150,0000 – 200,000
people recognizing they have dyskinesia. Parkinson’s disease is
characterized by dopamine deficiency combined with an
over-activated glutamate system, which contributes to the symptoms
of dyskinesia and OFF, which is characterized by slowness of
movement, rigidity, impaired walking, tremor, and postural
instability. Over time, nearly 90 percent of people with
Parkinson’s disease develop dyskinesia, which occurs throughout the
day. Dyskinesia is a consequence of levodopa-based treatment and
progression of Parkinson’s disease, and is characterized by
involuntary and non-rhythmic movements that are purposeless and
unpredictable, which often impacts the activities of daily living.
Until approval of GOCOVRI, the primary strategy to manage
dyskinesia has been to fractionate or lower the levodopa dose,
which may reduce dyskinesia in some cases, but because of the
reduced levodopa dosing, can lead to increased OFF in
patients.
About GOCOVRIGOCOVRI (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. GOCOVRI is a
high-dose 274 mg amantadine (340 mg amantadine hydrochloride) taken
once-daily at bedtime, which delivers high levels of amantadine
upon waking and throughout the day. Data from two pivotal,
placebo-controlled clinical studies in approximately 200 patients
demonstrated statistically significant reduction in dyskinesia, as
well as a secondary benefit in reducing OFF in patients dosed with
GOCOVRI. The most commonly observed adverse reactions with GOCOVRI
were hallucinations, dizziness, dry mouth, peripheral edema,
constipation, fall and orthostatic hypotension. For more
information about GOCOVRI, including complete safety information,
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 commercial launch of GOCOVRI™
(amantadine) extended release capsules (previously ADS-5102), 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, and delivering on its pipeline of differentiated
investigational programs. Those programs include: ADS-5102 in
development for the treatment of multiple sclerosis walking
impairment; and ADS-4101, a high-dose, modified release lacosamide
in development for the treatment of partial onset seizures in
patients with epilepsy. For more information about Adamas and its
unique approach to developing medicines based on time-dependent
biology, 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 the potential clinical benefits of GOCOVRI or
about Adamas’ ongoing or planned clinical development programs
because such statements are subject to risks and uncertainties,
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 ADS-5102, 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 3, 2018, 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.
Contact:
Media:
Terri Clevenger
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com
Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
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