- FDA analysis finds no new or unexpected
safety risks associated with NUPLAZID- Patients taking NUPLAZID for
Parkinson’s disease psychosis should continue to use it as
prescribed by their health care provider- FDA also reminds heath
care providers that no other antipsychotic medication is approved
for the treatment of Parkinson’s disease psychosis
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that
the FDA has completed a postmarketing review and issued a clear
statement reaffirming the positive benefit-risk profile of NUPLAZID
(pimavanserin) for patients with Parkinson’s disease psychosis.
NUPLAZID is the only medicine approved in the United States to
treat hallucinations and delusions associated with Parkinson’s
disease psychosis (PDP). NUPLAZID was approved by the FDA based on
a pivotal Phase 3 study that demonstrated clinically robust and
highly statistically significant efficacy, combined with other
supportive studies.
Following the FDA’s review, the FDA concluded, “The U.S. FDA has
completed a review of all postmarketing reports of deaths and
serious adverse events (SAEs) reported with the use of NUPLAZID.
Based on an analysis of all available data, FDA did not identify
any new or unexpected safety findings with NUPLAZID, or findings
that are inconsistent with the established safety profile currently
described in the drug label. After a thorough review, FDA’s
conclusion remains unchanged that the drug’s benefits outweigh its
risks for patients with hallucinations and delusions of Parkinson’s
disease psychosis.” In addition, the FDA stated that, “patients
taking NUPLAZID for Parkinson’s disease psychosis should continue
to use it as prescribed by their health care providers. Based on
this observation, FDA reminds health care providers to be aware of
the risks described in the prescribing information. FDA also
reminds health care providers that none of the other antipsychotic
medications are approved for the treatment of Parkinson’s disease
psychosis.”
“Nothing is more important to ACADIA than the wellbeing of the
patients who use NUPLAZID. We are very pleased with the FDA’s clear
statement reaffirming NUPLAZID’s positive benefit-risk profile,”
said Steve Davis, ACADIA’s President and Chief Executive Officer.
“We are also pleased with the FDA’s conclusion that patients taking
NUPLAZID for Parkinson’s disease psychosis should continue to use
it as prescribed by their health care provider and its reminder
that no other antipsychotic medication is approved for the
treatment of PDP.”
FDA Full Statement
FDA analysis finds no new or unexpected safety risks
associated with NUPLAZID (pimavanserin), a medication to treat the
hallucinations and delusions of Parkinson’s disease psychosis
(Link)
Health care providers reminded to follow prescribing
information
[09-20-2018] The U.S. Food and Drug Administration (FDA) has
completed a review of all postmarketing reports of deaths and
serious adverse events (SAEs) reported with the use of NUPLAZID
(pimavanserin). Based on an analysis of all available data, FDA did
not identify any new or unexpected safety findings with NUPLAZID,
or findings that are inconsistent with the established safety
profile currently described in the drug label. After a thorough
review, FDA’s conclusion remains unchanged that the drug’s benefits
outweigh its risks for patients with hallucinations and delusions
of Parkinson’s disease psychosis.
NUPLAZID and other antipsychotics have a Boxed Warning regarding
the increased risk of death in elderly patients with
dementia-related psychosis associated with the use of these drugs.
In view of the numbers of reports of death and other serious
adverse events, FDA conducted a comprehensive analysis of all
available information. This analysis included information submitted
to the FDA Adverse Event Reporting System (FAERS), drug utilization
data, safety data from the NUPLAZID new drug application, the
sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s
analysis of fatal adverse event reports with NUPLAZID and published
medical literature.
In assessing the reports of deaths, FDA considered that patients
with Parkinson’s disease psychosis, for whom NUPLAZID is indicated,
have a higher mortality (death) rate due to their older age,
advanced Parkinson’s disease, and other medical conditions.
Moreover, NUPLAZID is primarily distributed through a patient
support program and a specialty pharmacy network, which increases
the likelihood that deaths will be reported to the manufacturer. In
FAERS reports that included a cause of death (many reports did not
provide sufficient information to assess drug cause and effect),
there was no evident pattern to suggest a drug effect. Overall, the
postmarketing data were consistent with the safety data obtained
from the premarketing controlled clinical trials of NUPLAZID for
Parkinson’s disease psychosis.
Although FDA did not identify any new or unexpected safety
risks, some potentially concerning prescribing patterns were
observed, such as the concomitant use of other antipsychotic drugs
or drugs that can cause QT prolongation, a potential cause of heart
rhythm disorder. The risk of QT prolongation and serious arrhythmia
(abnormal heart rhythm) associated with NUPLAZID is noted in the
Warnings and Precautions section of the drug label, which warns of
the increased risks associated with using NUPLAZID together with
other drugs known to cause QT interval prolongation. Based on this
observation, FDA reminds health care providers to be aware of the
risks described in the prescribing information. FDA also reminds
heath care providers that none of the other antipsychotic
medications are approved for the treatment of Parkinson’s disease
psychosis.
Patients taking NUPLAZID for Parkinson’s disease psychosis
should continue to use it as prescribed by their health care
provider. FDA continues to monitor reports of adverse events
associated with NUPLAZID. The agency will communicate any updates
to the public as necessary. To help FDA assess potential medication
safety issues, we urge health care providers and patients to report
suspected side effects involving NUPLAZID and other drugs to the
FDA MedWatch program.
End of FDA Full Statement
About Parkinson’s Disease PsychosisAccording to the Parkinson’s
Foundation, about one million people in the United States and from
four to six million people worldwide suffer from Parkinson’s
disease. More than 50 percent of people with Parkinson’s will
experience symptoms of psychosis over the course of their disease.
PD Psychosis 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.
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. ACADIA discovered and developed
this new chemical entity and holds worldwide rights to develop and
commercialize NUPLAZID.
About ACADIA PharmaceuticalsACADIA is a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system disorders. ACADIA has developed and is
commercializing the first and only medicine approved for the
treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. In addition, ACADIA has ongoing
clinical development efforts in additional areas with significant
unmet need, including dementia-related psychosis, schizophrenia
inadequate response, schizophrenia-negative symptoms, major
depressive disorder and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
Forward-Looking StatementsStatements 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 NUPLAZID.
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,
approval and commercialization, 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, 2017 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.
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSISElderly 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.
Contraindication: NUPLAZID is contraindicated in patients with a
history of a hypersensitivity reaction to pimavanserin or any of
its components. Rash, urticaria, and reactions consistent with
angioedema (e.g., tongue swelling, circumoral edema, throat
tightness, and dyspnea) have been reported.
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: Coadministration with strong CYP3A4
inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce
NUPLAZID dose to 10 mg taken orally as one tablet once daily.
Coadministration with strong CYP3A4 inducers may reduce NUPLAZID
exposure. Monitor patients for reduced efficacy and an increase in
NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established in
pediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orally
once daily, without titration.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg
tablets.
For additional Important Safety Information, including Boxed
WARNING, please see the full Prescribing Information for NUPLAZID
at
https://www.NUPLAZID.com/pdf/NUPLAZID_Prescribing_Information.pdf.
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version on businesswire.com: https://www.businesswire.com/news/home/20180920005948/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Elena Ridloff,
CFA(858) 558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsBob Laverty(609)
558-5570bob@taftcommunications.com
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