Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the
U.S. Food and Drug Administration (FDA) has approved GOCOVRI
(amantadine) extended release capsules (previously ADS-5102) for
treatment of dyskinesia in patients with Parkinson’s disease
receiving levodopa-based therapy, with or without concomitant
dopaminergic medications. GOCOVRI, previously granted orphan drug
status by the FDA, is the first and only medicine approved by the
FDA for this indication.
“GOCOVRI’s approval is an important advancement
for the treatment of Parkinson’s disease, as it is the first
FDA-approved medicine for the treatment of dyskinesia in
Parkinson’s disease patients,” said Rajesh Pahwa, M.D., Laverne
& Joyce Rider Professor of Neurology at the Kansas Medical
Center and Director, Parkinson’s Disease Center of Excellence at
the University of Kansas Health System. “Notably, GOCOVRI is the
first Parkinson’s disease medicine proven in controlled trials to
reduce both dyskinesia and OFF time in Parkinson’s disease patients
receiving levodopa. Treatment of dyskinesia and OFF time continues
to be an unmet need in the medical management of Parkinson’s
disease and the approval of GOCOVRI is a major step in that
direction.”
GOCOVRI is a high dose 274 mg amantadine
(equivalent to 340 mg amantadine HCl) taken once-daily at bedtime
that delivers consistently high levels of amantadine from the
morning and throughout the day when dyskinesia occurs. Dyskinesia
is a consequence of levodopa-based Parkinson’s disease treatment
and is characterized by involuntary and non-rhythmic movements that
are purposeless and unpredictable, which impact the activities of
daily living.
“Dyskinesia can significantly compromise quality
of life for people with Parkinson’s disease,” said Dr. Todd Sherer,
Chief Executive Officer of The Michael J. Fox Foundation for
Parkinson's Research. “We are pleased that patients have another
option to manage this aspect of the disease and glad the Unified
Dyskinesia Rating Scale - a tool our support helped develop and
validate - could show clinical efficacy of GOCOVRI for the
treatment of dyskinesia.”
GOCOVRI’s positive benefit/safety profile was
established in two Phase 3 controlled clinical trials in
Parkinson’s disease patients with dyskinesia. In Study 1, patients
treated with GOCOVRI demonstrated statistically significant and
clinically relevant reductions in dyskinesia, with a 37 percent
reduction in Unified Dyskinesia Rating Scale (UDysRS) total score
vs. 12 percent for placebo at Week 12. These results were
confirmed in Study 2 in which GOCOVRI achieved a 46
percent reduction in UDysRS vs. 16 percent for placebo.
Additionally, key secondary data from Parkinson’s disease patient
reported diaries in Study 1 and Study 2 respectively, showed that
GOCOVRI-treated patients experienced a 3.6 and 4.0 hour increase in
functional time daily (defined as ON time without troublesome
dyskinesia) vs. a 0.8 and 2.1 hour increase for placebo-treated
patients at Week 12. The increases in functional time were achieved
by decreases in both ON time with troublesome dyskinesia and OFF
time. The placebo-adjusted reduction in OFF time in both studies
was approximately 1 hour per day. The most commonly observed
adverse reactions (>10 percent and greater than placebo)
with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral
edema, constipation, fall and orthostatic hypotension. For
additional Important Safety Information, see below.
“Today’s approval is a tremendous milestone for
Adamas and for the Parkinson’s disease community,” said Gregory T.
Went, Ph.D., Founder, Chairman and Chief Executive Officer of
Adamas Pharmaceuticals, Inc. “GOCOVRI has the potential to help
people with Parkinson’s disease suffering from dyskinesia by
finally providing physicians with an effective tool to address this
long-standing unmet medical need. We thank the physicians, clinical
staff, patients and their families who participated in the clinical
trials for making this advancement possible for the community.”
GOCOVRI is expected to be available in the
fourth quarter, and formally launched with the full deployment of
Adamas’s sales force in January 2018. Adamas developed GOCOVRI for
people with Parkinson’s disease and the company is committed to
helping them gain access. Adamas has created “GOCOVRI Onboard,” a
patient services program, which will facilitate access and
distribution. “GOCOVRI Onboard” will work with patients, their
families and physicians to obtain access to GOCOVRI via
reimbursement support, prescription fulfillment and financial
assistance. “GOCOVRI Onboard” is designed to deliver dedicated
assistance and financial support to patients in need.
Investor Conference Call and
Webcast Adamas will host a conference call and webcast
today, August 24, 2017, at 4:30 p.m. Eastern Time. The conference
call may be accessed by dialing 844-215-3280 for participants in
the U.S. or Canada and 484-747-6383 for international callers. The
webcast can be accessed live via the investor section of the Adamas
website at http://ir.adamaspharma.com/events.cfm and will be
available for replay until September 24, 2017.
About Parkinson’s Disease and
DyskinesiaParkinson’s disease is a chronic
neurodegenerative disorder affecting close to one million people in
the U.S. Parkinson’s disease results from a loss of dopamine in the
brain and is commonly treated by levodopa and dopaminergic
therapies that help replace lost dopamine. As the disease
progresses, people require increasingly higher or more frequent
doses of levodopa in order to avoid the recurrent periods of OFF
time – characterized by slowness of movement, rigidity, impaired
walking, tremor and postural instability – when the underlying
symptoms of Parkinson's disease return.
Over time, nearly 90 percent of people on
levodopa therapy experience dyskinesia, which is characterized by
involuntary and non-rhythmic movements during waking hours that are
purposeless and unpredictable. Dyskinesia can interfere with
people’s daily living, resulting in functional impairment and
disability. People with Parkinson’s disease often experience
multiple fluctuating periods of OFF time and dyskinesia during any
given day, which can impede their movement and daily function. In
the U.S., there are approximately 150,000 – 200,000 people with
Parkinson’s disease whose daily life is impacted by dyskinesia.
Until now, physicians have had limited options to manage, and have
had no approved medicines to treat dyskinesia.
About GOCOVRIGOCOVRI 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 taken
once-daily at bedtime, which delivers consistently high levels of
amantadine in the morning and throughout the day when dyskinesia is
most prevalent. GOCOVRI has received orphan drug status from the
FDA. For more information about GOCOVRI, including the full
Prescribing Information, please call 1-844-GOCOVRI [1-844-462-6874]
or visit www.GOCOVRI.com.
About Adamas Pharmaceuticals,
Inc.At Adamas, we believe in the power and the promise of
medicines derived from a deep understanding of time-dependent
biology. Our expertise lies in uncovering and mapping the
relationship between disease and drug activity. From there, we
strive to create medicines with therapeutic profiles that match the
pattern of disease to drive a more significant and durable clinical
effect. This understanding of time-dependent biological processes
informs our every innovation, targeting advancement in treatment of
chronic neurologic disorders. Our portfolio includes:
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; ADS-5102 in development for the treatment
of multiple sclerosis walking impairment and additional indications
in Parkinson’s disease, and ADS-4101, a high-dose, modified-release
lacosamide in Phase 1 clinical development for the treatment of
partial onset seizures in patients with epilepsy. Additionally,
Adamas’s 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.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONSGOCOVRI TM is
contraindicated in patients with creatinine clearance below 15
mL/min/1.73 m2.
WARNINGS AND PRECAUTIONSFalling
Asleep During Activities of Daily Living and Somnolence: Patients
treated with Parkinson’s disease medications have reported falling
asleep during activities of daily living. If a patient develops
daytime sleepiness during activities that require full attention
(e.g., driving a motor vehicle, conversations, eating), GOCOVRI
should ordinarily be discontinued or the patient should be advised
to avoid potentially dangerous activities. Suicidality and
Depression: Monitor patients for depression, including suicidal
ideation or behavior. Prescribers should consider whether the
benefits outweigh the risks of treatment with GOCOVRI in patients
with a history of suicidality or depression.
Hallucinations/Psychotic Behavior: Patients with a major psychotic
disorder should ordinarily not be treated with GOCOVRI because of
the risk of exacerbating psychosis. Observe patients for the
occurrence of hallucinations throughout treatment, especially at
initiation and after dose increases.Dizziness and Orthostatic
Hypotension: Monitor patients for dizziness and orthostatic
hypotension, especially after starting GOCOVRI or increasing the
dose. Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid
dose reduction or abrupt discontinuation of GOCOVRI, may cause an
increase in the symptoms of Parkinson’s disease or cause delirium,
agitation, delusions, hallucinations, paranoid reaction, stupor,
anxiety, depression, or slurred speech. Avoid sudden
discontinuation of GOCOVRI.Impulse Control/Compulsive Behaviors:
Patients may experience urges (e.g., gambling, sexual, money
spending, binge eating) and the inability to control them. It is
important for prescribers to ask patients or their caregivers about
the development of new or increased urges. Consider dose reduction
or stopping medications.
ADVERSE REACTIONSThe most
common adverse reactions (>10%) were hallucination, dizziness,
dry mouth, peripheral edema, constipation, fall, and orthostatic
hypotension.
DRUG INTERACTIONSOther
Anticholinergic Drugs: The dose of GOCOVRI should be reduced if
atropine-like effects are observed. Drugs Affecting Urinary
pH: The pH of the urine has been reported to influence the
excretion rate of amantadine. Monitor for efficacy or adverse
reactions under conditions that alter the urine pH.Alcohol:
Concomitant use with alcohol is not recommended, as it may increase
the potential for CNS effects such as dizziness, confusion,
lightheadedness, and orthostatic hypotension.
Forward-looking Statements
Statements contained in this press release regarding expected
future events 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 expected benefits of GOCOVRI, physician and
patient access in fourth quarter 2017 and launch of GOCOVRI
(amantadine) extended release capsules (previously ADS-5102) in
January 2018 for the treatment of dyskinesia in patients with
Parkinson’s disease receiving levodopa-based therapy, with or
without concomitant dopaminergic medications, and Adamas’ plans to
offer a number of programs providing patient access support
throughout the course of treatment, along with commercial copay
assistance and financial assistance for patients who are uninsured
or underinsured. Words such as “potentially,” “expected,”
“will,” “plans” and similar expressions (as well as other words or
expressions referencing future events, conditions, or
circumstances) are intended to identify forward-looking statements.
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, 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 August 8, 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:
Investor
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
Media
Kelley Kaufman
inVentiv Health
805-637-2491
Kelley.Kaufman@inventivhealth.com
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