-- New subgroup analyses showed that patients
previously treated with amantadine IR received benefit of ADS-5102
comparable to patients previously treated with placebo --
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the
presentation of an updated analysis of efficacy and tolerability
data from EASE LID 2, the company’s ongoing Phase 3 open-label,
long-term safety and efficacy study of ADS-5102 (amantadine)
extended-release capsules. Overall, results demonstrated that
ADS-5102 was well tolerated and the treatment effect on motor
complications, as measured by the Movement Disorder Society-Unified
Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV score, was
maintained for up to 88 weeks. Analyses of data from two subgroups
of patients, those who have undergone prior deep brain stimulation
(DBS) treatment and those who switched from amantadine
immediate-release (IR) to open-label ADS-5102, both showed a rapid
and sustained reduction in dyskinesia and OFF after introduction of
ADS-5102. The analyses were presented in a poster session at the
21st International Congress of Parkinson’s Disease and Movement
Disorders in Vancouver, Canada.
“These long-term, open-label data are
encouraging for physicians and their patients who are suffering
from dyskinesia,” said Dr. J. William Langston, M.D., Founder and
Chief Scientific Officer of the Parkinson’s Institute. “It is
particularly noteworthy that patients who were switched from
amantadine IR to ADS-5102 experienced continuing improvement in
dyskinesia and OFF during this open-label study and that this
improvement was comparable to that seen in patients who were
switched from placebo to ADS-5102.”
“The expanded analysis out to 88 weeks provides
continued support for the long-term safety and tolerability of
ADS-5102, as evidenced by a minimal discontinuation rate, and the
maintenance of a reduced and nearly constant level of dyskinesia
and OFF for over 12 months, as measured by MDS-UPDRS, Part IV,”
said Rajiv Patni, M.D., Chief Medical Officer of Adamas
Pharmaceuticals, Inc. “These open-label data, taken together with
the ADS-5102 Phase 3 data, suggest that ADS-5102 may have the
potential to transform the treatment landscape for dyskinetic
patients with Parkinson’s disease treated with levodopa. If
approved, ADS-5102 will be the first and only FDA-approved medicine
indicated for the treatment of levodopa-induced dyskinesia in
people with Parkinson’s disease, and we look forward to making this
treatment available to patients in need.”
Expanding on previously reported 64-week data,
this updated analysis demonstrated that the treatment effect of
ADS-5102 on motor complications, as accessed by MDS-UPDRS, Part IV
(a measurement of dyskinesia, OFF and dystonia), was durable and
maintained at a constant level for up to 88 weeks. Among patients
previously treated with amantadine IR, switching to open-label
ADS-5102 provided a 3 point, statistically significant reduction in
MDS-UPDRS Part IV at Week 8. The treatment effect experienced by
patients previously treated with amantadine IR was similar to that
experienced by previous placebo-treated patients, and was
maintained for up to 64 weeks. Patients who have undergone prior
DBS treatment and were switched to open-label ADS-5102 also
demonstrated a comparable reduction in the MDS-UPDRS, Part IV. All
subgroups achieved reductions in motor complications without
compromising the underlying control of Parkinson’s symptoms, as
assessed by Parts I-III of the MDS-UPDRS.
The safety data are consistent with the
previously reported safety profile of ADS-5102 and the known safety
profile of amantadine, which includes precautions and warnings
related to suicidality, hallucinations and dizziness. Approximately
50% of discontinuations due to adverse events (AEs) occurred within
the first month of treatment. The most common AEs, occurring in
five percent or more of patients in any group, included falls,
visual hallucinations, peripheral edema, constipation, livedo
reticularis, nausea, dry mouth, insomnia and dizziness.
About the EASE LID 2 Open-label Safety
StudyThe EASE LID 2 study is an ongoing Phase 3
open-label, long-term safety study of ADS-5102 for the treatment of
levodopa-induced dyskinesia (LID) in 223 patients with Parkinson’s
disease. The study enrolled patients from the three ADS-5102
placebo-controlled LID efficacy trials (EASED, EASE LID and EASE
LID 3), as well as Parkinson’s disease patients with LID who have
undergone deep brain stimulation (DBS) treatment. Patients are
being followed for up to two years. The primary objective of the
study is to characterize the long-term safety and tolerability of
ADS-5102 dosed once daily at bedtime for the treatment of LID in
patients with Parkinson’s disease. Secondary objectives include
evaluating the durability of ADS-5102 on motor complications
(dyskinesia and OFF) as assessed by the MDS-UPDRS, Part IV, as well
as evaluating the clinical progression of Parkinson’s disease.
About ADS-5102 ADS-5102 is a
high-dose amantadine, taken once daily at bedtime, in development
for the treatment of LID in people with Parkinson's disease. A New
Drug Application (NDA) supporting ADS-5102 for the treatment of LID
in people with Parkinson's disease is under review by the U.S. Food
and Drug Administration (FDA), with a Prescription Drug User Fee
Act (PDUFA) date of August 24, 2017. If approved, ADS-5102 will be
the first and only FDA-approved medicine indicated for the
treatment of LID in people with Parkinson's disease. Adamas is also
investigating ADS-5102 for the treatment of walking impairment in
people with multiple sclerosis and is considering developing it for
other indications earlier in the Parkinson's disease treatment
journey.
About Parkinson's Disease and
Levodopa-induced Dyskinesia Parkinson's disease is a
chronic neurodegenerative disorder affecting close to 1 million
people in the United States. It is characterized by the progressive
loss of dopaminergic neurons, causing lower levels of endogenous
dopamine and manifesting as symptoms of bradykinesia (slowness of
movement), rigidity, impaired walking, tremor and postural
instability.
Levodopa, which replaces lost dopamine, is the
most effective therapy for all stages of Parkinson's disease and is
considered the "gold standard" therapy. Over time, people require
increasingly higher or more frequent doses of levodopa in order to
avoid the recurrent periods of OFF time when the underlying
symptoms of Parkinson’s disease return. As Parkinson’s disease
progresses, nearly all people on levodopa therapy will also
experience LID, which is characterized by involuntary movements
that are non-rhythmic, purposeless and unpredictable. Symptoms of
OFF time are characterized by slowness of movement, rigidity,
impaired walking, tremor and postural instability. These people
often experience multiple fluctuating periods of OFF time and LID
during any given day, which can impede their movement and daily
function. In the United States, approximately 150,000 to 200,000
people with Parkinson’s suffer from LID.
About Adamas Pharmaceuticals,
Inc.Adamas develops new medicines to improve the daily
lives of those affected by chronic neurologic disorders, including
Parkinson’s disease, multiple sclerosis, epilepsy, and Alzheimer’s
disease. Adamas has pioneered a platform to develop medicines for
chronic neurologic disorders based on an understanding of the
time-dependent biologic processes responsible for disease activity
and drug response. The company’s most advanced product candidate,
ADS-5102, is a high-dose amantadine, taken once daily at bedtime,
in development for levodopa-induced dyskinesia in people with
Parkinson’s disease and for the treatment of walking impairment in
people with multiple sclerosis. A New Drug Application supporting
ADS-5102 for the treatment of levodopa-induced dyskinesia in people
with Parkinson’s disease is under review by the FDA with a PDUFA
date of August 24, 2017. Adamas is exploring other indications for
further development of ADS-5102. Adamas is also investigating
ADS-4101 for the treatment of partial onset seizures in patients
with epilepsy. Additionally, Adamas’ licensed assets, are currently
marketed by Allergan under the brand names NAMENDA XR® and
NAMZARIC®, and Adamas is eligible to receive royalties on sales of
these medicines beginning in June 2018 and May 2020, respectively.
For more information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz
Pharma GmbH & Co. KGaA.
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 approval of ADS-5102 for the
treatment of levodopa-induced dyskinesia in people with Parkinson's
disease and the potential clinical benefits of ADS-5102. 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 ADS-5102 and ADS-4101, 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 9, 2017. 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:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3528
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
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