-- Patients receiving GOCOVRI experienced
long-term durability for up to two years --
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced positive
data from EASE LID 2, the company’s two-year Phase 3 open-label
study of GOCOVRI™ (amantadine) extended release capsules, the first
and only medicine approved by the U.S. Food and Drug Administration
(FDA) for the treatment of dyskinesia in patients with Parkinson's
disease receiving levodopa-based therapy, with or without
concomitant dopaminergic medications. Overall, results demonstrated
that GOCOVRI was generally well tolerated and the treatment effect
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 up to two years. This
effect was seen in all subgroups, including those switched to
GOCOVRI from placebo or amantadine immediate release (IR), as well
as a subgroup of patients with uncontrollable dyskinesia after deep
brain stimulation (DBS) treatment. These data are planned to be
presented at the 22nd International Congress of Parkinson’s Disease
and Movement Disorders (MDS) in Hong Kong, China.
“The completed Phase 3 open-label study further
expands our understanding of the benefit/risk profile of GOCOVRI,”
said Rajiv Patni, M.D., Chief Medical Officer of Adamas
Pharmaceuticals, Inc. “The large reduction in dyskinesia and OFF,
as assessed by the Part IV score of the MDS-UPDRS, was observed by
the first visit at Week 8 and was sustained for two years. This
durability is noteworthy given the known progression of motor
complications. Nine percent of patients discontinued GOCOVRI due to
an adverse drug reaction over this prolonged treatment period and
the safety as well as tolerability remained consistent with that
obtained from the 64-week data cut from December 2016. Lastly, by
two years, 30 percent of patients increased their levodopa dose by
an average of approximately 300 mg, suggesting that GOCOVRI
treatment may allow neurologists to further optimize their
patient’s levodopa dose despite the occurrence of dyskinesia.”
“When coupled with the Phase 3 controlled
studies, this completed open-label study provides supportive
evidence that GOCOVRI was able to provide a treatment effect for up
to 100 weeks, without waning of benefit in the majority of
patients,” stated Robert Hauser, M.D., MBA, Professor of Neurology,
Director, USF Health Byrd Parkinson's Disease and Movement
Disorders Center, Parkinson Foundation Center of Excellence. “These
data suggest that further research is warranted to assess whether
GOCOVRI could potentially delay the onset or reduce the progression
of motor complications.”
This final analysis extends and confirms the
previously reported results from the 64-week interim analysis
published in the Journal of Parkinson’s Disease in 2017. At Week
100, the change from baseline in the MDS-UPDRS, Part IV, score was
a decrease of -2.4, -3.5, -3.6 units, in patients previously
treated with placebo, amantadine IR and DBS, respectively. In
contrast, the change from baseline in the previously treated
GOCOVRI patients was 0.4 units, demonstrating little change in
patients who were already receiving GOCOVRI prior to entry in this
open-label study.
The safety data are consistent with the
previously reported safety profile of GOCOVRI, which includes
precautions and warnings related to suicidality, hallucinations,
dizziness and orthostatic hypotension. During the two-year study,
nine percent of patients discontinued due to adverse drug reactions
(ADRs). Most adverse drug reactions were of mild to moderate
intensity, and the most common adverse drug reactions (≥5%) were
falls, hallucination, peripheral edema, constipation, urinary tract
infection, dizziness, nausea, insomnia, livedo reticularis, dry
mouth, depression, anxiety and abnormal dreams. Nine patients died
during the course of the study because of cardiac arrest,
pneumonia, sepsis, or natural causes; none were deemed study drug
related.
About the EASE LID 2 Open-label Safety
StudyThe EASE LID 2 study is a two-year Phase 3 open-label
study of GOCOVRI in 223 Parkinson’s disease patients with
dyskinesia on levodopa-based therapy. The study enrolled patients
from the three GOCOVRI placebo-controlled dyskinesia efficacy
trials (EASED, EASE LID and EASE LID 3), as well as Parkinson’s
disease patients with dyskinesia who have undergone deep brain
stimulation (DBS) treatment. The primary objective of the study was
to characterize the long-term safety and tolerability of GOCOVRI
dosed once-daily at bedtime for the treatment of dyskinesia in
patients with Parkinson’s disease. Secondary objectives include
evaluating the durability of GOCOVRI 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, as
assessed by the MDS-UPDRS, Parts I, II, and III.
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 OFF time 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’ Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 22, 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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