U.S. Commercial Launch Planned for June
2016
An Estimated 40 Percent of Parkinson’s
Disease Patients Have Psychosis
Conference Call Scheduled on Monday, May 2
at 8:30 a.m. ET
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system (CNS) disorders, today announced that the U.S. Food
and Drug Administration (FDA) has approved NUPLAZID (pimavanserin)
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID
as a Breakthrough Therapy for this condition.
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NUPLAZID™ (pimavanserin) bottle (Photo:
Business Wire)
“Today’s approval of NUPLAZID represents a major paradigm shift
in the treatment of Parkinson’s disease psychosis,” said Michael S.
Okun, M.D., Medical Director of The National Parkinson Foundation.
“Through its novel and selective mechanism of action, NUPLAZID is a
breakthrough treatment that works in a whole new way - treating
hallucinations and delusions without blocking dopamine receptors
and, therefore, not impairing motor function in Parkinson’s
psychosis patients.”
NUPLAZID is the first and only medicine to be approved by the
FDA for this indication. NUPLAZID is also the only drug approved by
the FDA that preferentially targets 5-HT2A receptors. These
receptors are thought to play an important role in Parkinson’s
disease psychosis. The unique pharmacology of NUPLAZID establishes
a new class of drug - selective serotonin inverse agonists (SSIA) -
by not only preferentially targeting 5-HT2A receptors but also
avoiding activity at dopamine and other receptors commonly targeted
by antipsychotics. Typical Parkinson’s disease therapy consists of
drugs that stimulate dopamine to treat patients’ motor symptoms
such as tremor, muscle rigidity and difficulty with walking.
NUPLAZID does not interfere with patients’ dopaminergic therapy and
therefore does not impair their motor function.
According to the National Parkinson Foundation, about one
million people in the United States and from four to six million
people worldwide suffer from Parkinson’s disease. An estimated 40
percent of these patients have Parkinson’s disease psychosis, which
is characterized by hallucinations and delusions, is associated
with significant caregiver burden, and is a major reason for
nursing home placement among Parkinson’s patients.
“NUPLAZID represents a major medical advancement for patients
with Parkinson’s disease psychosis who suffer from hallucinations
and delusions,” said Steve Davis, ACADIA’s President and Chief
Executive Officer. “We are grateful to the many patients and
investigators who participated in NUPLAZID’s clinical studies.
NUPLAZID represents the culmination of many years of work across
our entire organization to bring this novel medicine, discovered by
our scientists, to patients in need.”
“Parkinson’s disease psychosis is a debilitating condition that
adds a tremendous burden on the lives of patients already
contending with motor issues such as slow movement, loss of
balance, and muscle rigidity,” said Todd Sherer, Ph.D., Chief
Executive Officer of the Michael J. Fox Foundation. “It also places
an increased burden on caregivers and can lead to loss of
independence and nursing home admittance for patients. A therapy to
treat the hallucinations and delusions associated with Parkinson’s
disease psychosis without worsening motor symptoms can
significantly impact the lives of Parkinson’s patients and their
loved ones.”
Clinical Data
The FDA approval of NUPLAZID was based on data from the pivotal
Phase III Study -020 and other supportive studies, representing the
largest research and development program in Parkinson’s disease
psychosis to date. In Study -020, NUPLAZID significantly reduced
the frequency and severity of psychotic symptoms compared to
placebo on the Scale for Assessment of Positive Symptoms –
Parkinson’s Disease (SAPS-PD). This benefit was achieved without
impairing motor function. The most common adverse reactions (≥5%
and twice the rate of placebo) in this study were peripheral edema
(7% NUPLAZID vs 3% placebo) and confusional state (6% NUPLAZID vs
3% placebo). Results of Study -020 were published in The Lancet.
Please see full prescribing information at www.nuplazid.com.
Introducing NUPLAZIDconnect™ Patient Access and Support
Services
ACADIA plans to make NUPLAZID commercially available to patients
suffering from hallucinations and delusions associated with
Parkinson’s disease psychosis in the United States in June 2016.
ACADIA is committed to ensuring that patients in the United States
who are prescribed NUPLAZID are able to access the medicine and
receive the ongoing support they may need. ACADIA will be
introducing NUPLAZIDconnect, a comprehensive program that provides
financial assistance and/or access assistance to patients, their
caregivers, and physicians. NUPLAZID will be available through a
specialty pharmacy network. Patients and physicians can access
information about NUPLAZID and NUPLAZIDconnect by visiting
www.nuplazid.com or calling 844-737-2223.
Important Safety Information and
Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk
of death. NUPLAZID is not approved for the treatment of patients
with dementia-related psychosis unrelated to the hallucinations and
delusions associated with Parkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the
treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The
use of NUPLAZID should be avoided in patients with known QT
prolongation or in combination with other drugs known to prolong QT
interval including Class 1A antiarrhythmics or Class 3
antiarrhythmics, certain antipsychotic medications, and certain
antibiotics. NUPLAZID should also be avoided in patients with a
history of cardiac arrhythmias, as well as other circumstances that
may increase the risk of the occurrence of torsade de pointes
and/or sudden death, including symptomatic bradycardia, hypokalemia
or hypomagnesemia, and presence of congenital prolongation of the
QT interval.
Adverse Reactions: The most common adverse reactions (≥2% for
NUPLAZID and greater than placebo) were peripheral edema (7% vs
2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination
(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs
<1%).
Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)
increase NUPLAZID concentrations. Reduce the NUPLAZID dose by
one-half.
Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for
reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in
patients with mild to moderate renal impairment. Use of NUPLAZID is
not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in
patients with hepatic impairment. NUPLAZID has not been evaluated
in this patient population.
Pediatric Use: Safety and efficacy have not been established in
pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day,
taken orally as two 17 mg tablets once daily, without
titration.
Conference Call
ACADIA will hold a conference call and webcast on Monday, May 2,
2016 at 8:30 a.m. ET to discuss the FDA approval of NUPLAZID. The
conference call may be accessed by dialing 844-821-1109 for
participants in the U.S. or Canada and 830-865-2550 for
international callers (reference passcode 3844233). A telephone
replay of the conference call may be accessed through May 16, 2016
by dialing 855-859-2056 for callers in the U.S. or Canada and
404-537-3406 for international callers (reference passcode
3844233). The conference call also will be webcast live on ACADIA’s
website, www.acadia-pharm.com, under the investors section and will
be archived there until May 16, 2016.
About NUPLAZID™ (pimavanserin)
NUPLAZID is the first FDA-approved treatment for hallucinations
and delusions associated with Parkinson’s disease psychosis.
NUPLAZID is a non-dopaminergic, selective serotonin inverse agonist
preferentially targeting 5-HT2A receptors that are thought to play
an important role in Parkinson’s disease psychosis. NUPLAZID is an
oral medicine taken once a day with a recommended dose of 34 mg
(two 17 mg tablets). ACADIA discovered this new chemical entity and
holds worldwide rights to develop and commercialize NUPLAZID.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in central nervous system disorders. ACADIA maintains
a website at www.acadia-pharm.com to which we regularly post copies
of our press releases as well as additional information and through
which interested parties can subscribe to receive e-mail
alerts.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include but are not limited to statements related to the
benefits to be derived from ACADIA’s product candidates, including
NUPLAZID (pimavanserin); whether NUPLAZID represents a paradigm
shift in the treatment of Parkinson’s disease psychosis (PDP)
patients; whether NUPLAZID is a breakthrough treatment that works
in a whole new way; whether NUPLAZID establishes a new class of
drug; whether NUPLAZID represents a major medical advancement for
PDP patients who suffer from hallucinations and delusions; whether
a therapy to treat the hallucinations and delusions associated with
PDP without worsening motor symptoms can significantly impact the
lives of Parkinson’s patients and their loved ones; ACADIA’s plans
to make NUPLAZID commercially available in the United States,
including the timing thereof; whether ACADIA will be able to ensure
patients have access to NUPLAZID; and the assistance that will be
available to patients, their caregivers and physicians from ACADIA,
including through NUPLAZIDconnect. These statements are only
predictions based on current information and expectations and
involve a number of risks and uncertainties. Actual events or
results may differ materially from those projected in any of such
statements due to various factors, including the risks and
uncertainties inherent in drug discovery, development, and
commercialization, whether NUPLAZID receives adequate reimbursement
from third-party payers, ACADIA’s ability to establish an adequate
specialty pharmacy network to distribute NUPLAZID, the degree to
which NUPLAZID receives acceptance from patients and physicians for
its approved indication, and the fact that past results of clinical
trials may not be indicative of future trial results. For a
discussion of these and other factors, please refer to ACADIA’s
annual report on Form 10-K for the year ended December 31, 2015 as
well as ACADIA’s subsequent filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20160429006144/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy(858)
558-2871orMedia Contact:Taft and PartnersTed Deutsch(609)
578-8765ted@taftandpartners.com
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