Adamas announces FDA filing acceptance of sNDA to modify the indication statement for GOCOVRI® to include treatment for Park...
June 04 2020 - 4:30PM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, today
announced that its supplemental New Drug Application (sNDA) for
GOCOVRI as a treatment for OFF episodes in Parkinson’s disease (PD)
patients receiving levodopa-based therapy has been accepted for
review by the U.S. Food and Drug Administration (FDA). The
anticipated Prescription Drug User Fee Act (PDUFA) action date is
February 1, 2021.
GOCOVRI (amantadine) extended release capsules
is approved to treat dyskinesia in PD patients treated with
levodopa-based therapy, with or without other dopaminergic
medications. In the sNDA, Adamas has proposed a revision to the
indication statement to include GOCOVRI as an appropriate therapy
for the treatment of OFF episodes in PD patients receiving
levodopa. The clinical evidence supporting GOCOVRI’s effect on OFF
time was demonstrated in two large pivotal Phase 3 trials and is
currently included in the GOCOVRI prescribing information.
“We are pleased the FDA has accepted our sNDA
for review. If approved, the indication would reflect the full
spectrum of GOCOVRI’s therapeutic benefit in PD motor complications
and better support physicians to identify appropriate treatments
for their patients,” said Neil F. McFarlane, Chief Executive
Officer. “Many PD medications necessitate a trade-off between
reducing OFF time and exacerbating levodopa-induced dyskinesia.
GOCOVRI is the first medication clinically proven to reduce
both.”
About
GOCOVRI®GOCOVRI® (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. It is also the only medicine
clinically proven to reduce both dyskinesia and OFF. Taken once
daily at bedtime, GOCOVRI provides an initial lag and a slow rise
in amantadine concentration during the night, resulting in a high
concentration from the morning and throughout the waking day.
Additionally, in the clinical trials, the adjunctive use of GOCOVRI
did not require dose changes to dopaminergic therapies. The
most commonly observed adverse reactions with GOCOVRI were
hallucinations, dizziness, dry mouth, peripheral edema,
constipation, falls and orthostatic hypotension.For more
information about GOCOVRI, please visit www.GOCOVRI.com.
About Parkinson’s disease, dyskinesia
and OFFParkinson’s disease (PD) is a progressive,
neurodegenerative disorder caused by the gradual loss of brain
cells that produce the neurotransmitter dopamine and affects
approximately one million people in the United States. Dopamine
decline in the brain results in a wide range of motor
(movement-related) and non-motor symptoms. As the disease
progresses, people are likely to experience unpredictable
stiffness, rigidity and tremors, referred to as OFF time. The
primary treatment for PD is with levodopa; however, over time
levodopa may lead to involuntary, uncontrolled movements known as
dyskinesia. The abrupt and unpredictable transitions between
episodes of dyskinesia, normal movement and OFF time lead to
considerable impact on patients’ lives.
About AdamasAt Adamas our
vision is clear – to deliver innovative medicines that reduce the
burden of neurological diseases on patients, caregivers and
society. We are a fully integrated company focused on growing a
portfolio of therapies to address a range of neurological diseases.
For more information, please visit www.adamaspharma.com.
Forward-looking
statementsStatements contained in this press release
regarding matters that may occur in the future, including the
expectations as to the long-term benefits of GOCOVRI, are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to risks and uncertainties, and 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’
commercial activities relating to GOCOVRI, and 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 7, 2020, 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, except as required
by law.
Contact:
Media Sarah Mathieson Vice President of Corporate
Communications 510-450-3528smathieson@adamaspharma.com |
Investors Peter Vozzo Managing Director, Westwicke
443-213-0505peter.vozzo@westwicke.com |
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