Adamas Announces Publication of Pharmacokinetic Data for GOCOVRI™ in Clinical Pharmacokinetics
May 24 2018 - 9:05AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that
pharmacokinetic (PK) data regarding GOCOVRI™ (amantadine) extended
release capsules were published online in Clinical
Pharmacokinetics. The paper, entitled Pharmacokinetics of ADS-5102
(Amantadine) Extended Release Capsules Administered Once-Daily at
Bedtime for the Treatment of Dyskinesia concluded that GOCOVRI
demonstrated a slow initial rise in amantadine plasma concentration
and can be dosed effectively once-daily at bedtime to achieve high
amantadine plasma concentrations upon waking and during the
day.
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 in these patients, as well as demonstrate a
secondary benefit in OFF.
“Dyskinesia in Parkinson’s disease patients
typically occurs in the morning and throughout the waking day when
patients take their levodopa. This is when they need the most help
in managing their symptoms, including dyskinesia and OFF,” said
Robert A. Hauser MD, MBA, Professor of Neurology and Director, USF
Health Byrd Parkinson’s Disease and Movement Disorders Center
Parkinson Foundation Center of Excellence. “The PK data reported in
this paper show that GOCOVRI has a significantly different profile
than amantadine immediate release, allowing for a bedtime dose
resulting in a slow rise to the high plasma concentration upon
waking prior to taking dopaminergic treatments.”
The publication reported on three studies to
evaluate the single-dose and steady-state PK of GOCOVRI in healthy
volunteers, directly comparing with corresponding PK values for
amantadine immediate release (IR), along with the steady-state PK
in patients with Parkinson’s disease. When administered at bedtime,
GOCOVRI’s profile results in high amantadine plasma concentrations
upon waking and throughout the day, with lower amantadine plasma
concentrations in the evening. In contrast, amantadine IR dosed two
to three times during the day was characterized by low amantadine
plasma concentrations upon waking with higher amantadine plasma
concentrations in the evening into the night, potentially
contributing to sleep related adverse events associated with high
doses of amantadine. At the approved recommended dosage of 274 mg
given once-daily at bedtime, GOCOVRI provided 3.0- and 2.0-fold
higher amantadine plasma concentrations upon waking, compared to
amantadine IR given two or three times during the day,
respectively.
“This publication provides a clear picture of PK
data to date from Adamas’ clinical pharmacology program,” said
Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals,
Inc. “The data support GOCOVRI’s unique PK profile, which is
distinctly different from the PK curves achieved with the commonly
prescribed dosing regimens of amantadine immediate release. The PK
profile of GOCOVRI achieved with once-daily bedtime dosing results
in high amantadine concentrations before the patient has taken
their first levodopa dose and has yet to experience the
unpredictable episodes of dyskinesia and OFF that invariably occur
during waking hours. These studies demonstrate that GOCOVRI is
significantly different than amantadine IR and that the two
formulations are not bioequivalent either at single dose or at
steady-state.”
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 time, 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 time 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 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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