Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced it will
make six data presentations at the 70th Annual Meeting of the
American Academy of Neurology (AAN) on April 21-27, 2018 in Los
Angeles, California. Adamas will present one platform presentation
and four poster presentations regarding GOCOVRI™ (amantadine)
extended release capsules, 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. In addition, Adamas
will present one poster on ADS-4101 (lacosamide) modified release
capsules, in development for the treatment of partial onset
seizures in epilepsy.
“These data presentations confirm just how
critical understanding symptom timing patterns and designing drug
delivery profiles are to developing clinically differentiated
medicines that provide large and durable effects for people
suffering from chronic neurological diseases,” said Rajiv Patni,
MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “Of note,
new data will be presented at AAN from the development program of
GOCOVRI for the treatment of dyskinesia in people with Parkinson’s
disease, including the impact of rate-of-rise in amantadine
concentrations on tolerability; the pharmacokinetic profile;
effects on non-motor symptoms; and the clinically important
differences on the Unified Dyskinesia Rating Scale. These important
data further add to the robust medical literature available in
support of GOCOVRI.”
Details of the presentations are listed
below.
GOCOVRI Poster PresentationsAbstract
2987 / Poster 039: “Effects of ADS-5102 on Non-motor
Symptoms (NMS) in Parkinson's Disease Patients with
Dyskinesia”Presenter: Shyamal Mehta, M.D., Ph.D.
Assistant Professor, Movement Disorders, Mayo Clinic -
ArizonaDate and Time: Sunday, April 22, 2018; 4:00
p.m. – 5:30 p.m.
Abstract 1502 / Poster 052: “A
Clinically Important Difference (CID) for the Unified Dyskinesia
Rating Scale (UDysRS) Total Score Change in Parkinson's Disease
(PD) Patients with Dyskinesia”Presenter: Rajesh
Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology and
Director of the Parkinson's Disease and Movement Disorder Center at
the University of Kansas Medical CenterDate and
Time: Monday, April 23, 2018; 5:30 p.m. – 7:00 p.m.
Abstract 1476 / Poster 043:
“Pharmacokinetics of ADS-5102 (amantadine) Extended Release
Capsules Administered Once-Daily at Bedtime for the Treatment of
Dyskinesia”Presenter: Robert Hauser, M.D.,
MBA,Professor of Neurology, Director, USF Health Byrd Parkinson’s
Disease and Movement Disorders Center Parkinson Foundation Center
of ExcellenceDate and Time: Monday, April 23,
2018; 5:30 p.m. – 7:00 p.m.
Abstract 1499 / Poster 064:
“Extended-release (ER) Formulations of Aminoadamantanes as
NMDA-receptor Antagonists: Pharmacokinetic (PK) Determinants of
Improved Tolerability”Presenter: Jack Nguyen,
Ph.D., Vice President, Research, Adamas Pharmaceuticals,
Inc.Date and Time: Thursday, April 26, 2018; 5:30
p.m. – 7:00 p.m.
GOCOVRI Platform PresentationAbstract
1476 / Platform 006: “Pharmacokinetic/Pharmacodynamic
Analysis of Amantadine for Levodopa-Induced Dyskinesia: Correlation
of Therapeutic Plasma Concentrations from Multiple Species with
Humans”Presenter: Jack Nguyen, Ph.D., Vice
President, Research, Adamas Pharmaceuticals, Inc.Platform
Session Number: S45 - Movement Disorders: Parkinsonian
Disorders, Basic Science, and Imaging Date and
Time: Thursday, April 26, 2018; 4:30 p.m.
ADS-4101 Poster PresentationAbstract
3563 /Poster 263: “Pharmacokinetic Evaluations of ADS-4101
(Lacosamide) Modified Release Capsules Versus Lacosamide IR in Two
Phase 1 Studies up to 600 mg”Presenter: Rajiv
Patni, M.D., Chief Medical Officer, Adamas Pharmaceuticals,
Inc.Date and Time: Sunday, April 22, 2018; 4:00
p.m. – 5:30 p.m.
About GOCOVRIGOCOVRI
(amantadine) extended release capsules is the first and only
medicine approved by the FDA 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 consistently 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 ADS-4101ADS-4101 is an
investigational drug in development for the treatment of partial
onset seizures in patients with epilepsy. Derived from Adamas’
validated time-dependent biology approach to drug development,
ADS-4101 is a potential high-dose, once-daily at bedtime lacosamide
therapy, with a drug profile that provides high concentrations of
lacosamide during the day to match the time when seizures occur
most often. Lacosamide is an anti-epilepsy active ingredient
previously approved by the FDA and currently marketed as VIMPAT®
(lacosamide).
About Adamas Pharmaceuticals, Inc.Adamas
is using its deep understanding of time-dependent biology to
redefine the treatment experience for patients suffering from
chronic neurological diseases. 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. Adamas’ goal is to create
and commercialize a new generation of neurological medicines
intended to lessen the burden of disease on patients, caregivers
and society. 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, ADS-5102 and ADS-4101, 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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