Acadia Pharmaceuticals Announces Outcome of FDA Advisory Committee for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis
June 17 2022 - 8:00PM
Business Wire
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the
outcome of the U.S. Food and Drug Administration (FDA)
Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for
pimavanserin for the treatment of hallucinations and delusions
associated with Alzheimer’s disease psychosis (ADP). The PDAC voted
9 to 3 that the evidence presented does not support a conclusion
that pimavanserin is effective for the treatment of hallucinations
and delusions in the ADP population.
“We are disappointed with the outcome of today’s vote. We will
continue to work closely with the FDA as it completes its review of
the totality of our efficacy and safety data to enable a full
assessment of pimavanserin’s benefit-risk in patients with ADP,”
said Steve Davis, Chief Executive Officer. “We continue to believe
there is substantial evidence across multiple independent clinical
studies and endpoints that support the efficacy of pimavanserin in
ADP. There are no FDA approved treatments for this critical public
health need and off-label use of multi-receptor acting
antipsychotics have demonstrated poor patient outcomes, including
worsening of cognition and motor function.”
The FDA asked the PDAC today for advice and recommendations
regarding the evidence that pimavanserin is effective for the
treatment of hallucinations and delusions associated with ADP. The
FDA is not bound by the PDAC’s recommendations, but takes its
advice into consideration when making decisions on drug
applications. The FDA’s target action date is August 4, 2022.
NUPLAZID was approved in the U.S. in 2016 as the first and only
treatment for hallucinations and delusions associated with
Parkinson’s disease psychosis (PDP). The totality of clinical
trial, post-marketing and observational real-world evidence
continue to support a positive benefit-risk profile for NUPLAZID
for the treatment of hallucinations and delusions associated with
PDP.
About Alzheimer’s Disease Psychosis
According to the Alzheimer’s Association, approximately six
million people in the United States are living with Alzheimer’s
disease (AD).1-2 Approximately 30% of patients with AD experience
psychosis, commonly consisting of hallucinations and delusions.3
These symptoms may be frequent and severe and may recur over time.4
A hallucination is defined as a perception-like experience that
occurs without an external stimulus and is sensory (seen, heard,
felt, tasted, sensed, smelled) in nature. A delusion is defined as
a false, fixed belief despite evidence to the contrary. Serious
consequences have been associated with psychosis in patients with
dementia, such as increased likelihood of nursing home placement,
more severe dementia, and increased risk of morbidity and
mortality.5-6 There is no FDA approved drug for the treatment of
Alzheimer’s disease psychosis.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist and
antagonist preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in neuropsychiatric
disorders. In vitro, pimavanserin demonstrated no appreciable
binding affinity for dopamine (including D2), histamine,
muscarinic, or adrenergic receptors. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug
Administration in April 2016 under the trade name NUPLAZID®.
NUPLAZID is not approved for Alzheimer’s disease psychosis. In
addition, Acadia is developing pimavanserin in other
neuropsychiatric conditions.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate
life. For more than 25 years we have been working at the forefront
of healthcare to bring vital solutions to people who need them
most. We developed and commercialized the first and only approved
therapy for hallucinations and delusions associated with
Parkinson’s disease psychosis. Our late-stage development efforts
are focused on treating psychosis in patients with dementia, the
negative symptoms of schizophrenia and Rett syndrome. Our
early-stage development efforts are focused on novel approaches to
pain management, cognition and neuropsychiatric symptoms in central
nervous system disorders. For more information, visit us at
www.acadia.com and follow us on LinkedIn and Twitter.
Important Safety Information and Indication for NUPLAZID®
(pimavanserin)
Indication
NUPLAZID is indicated for the treatment of hallucinations and
delusions associated with Parkinson’s disease psychosis.
Important Safety Information
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.
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.
Warnings and Precautions: 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 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 or moderate CYP3A4 inducers
reduces NUPLAZID exposure. Avoid concomitant use of strong or
moderate CYP3A4 inducers with NUPLAZID.
Dosage and Administration
Recommended dose: 34 mg capsule taken orally once daily, without
titration. NUPLAZID is available as 34 mg capsules and 10 mg
tablets. Please read the full Prescribing Information including
Boxed WARNING.
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 regarding the
timing of future events. 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 development, approval and commercialization. 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, 2021 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.
References 1 Alzheimer’s Association. 2021 Alzheimer’s Disease
Facts and Figures. Alzheimer’s Dement. 2021; 16(3): 391. 2 Rajan,
KB et al. Population estimate of people with clinical Alzheimer’s
disease and mild cognitive impairment in the United States
(2020-2060). Alzheimer’s and Dementia. 2021: 1-10. 3 Cummings J et
al. Criteria for Psychosis in Major and Mild Neurocognitive
Disorders: International Psychogeriatric Associations (IPA)
Consensus Clinical and Research Definition. Am J of Geriatric
Psychiatry. 2020; 28(12): 1256-1269. 4 Ballard C et al. A
prospective study of psychotic symptoms in dementia sufferers:
psychosis in dementia. Int Psychogeriatr. 1997; 9(1): 57-64. 5
Scarmeas N et al. Delusions and hallucinations are associated with
worse outcome in Alzheimer Disease. Arch Neurol. 2005; 62(10):
1601-1608. 6 Peters ME et al. Neuropsychiatric symptoms as
predictors of progression to severe Alzheimer’s dementia and death:
the Cache County Dementia Progression study. Am J Psychiatry. 2015;
172(5): 460-465.
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version on businesswire.com: https://www.businesswire.com/news/home/20220617005539/en/
Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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