Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the Alzheimer’s Asso...
July 14 2021 - 9:00AM
Business Wire
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
three scientific presentations in dementia-related psychosis (DRP)
will be shared at the Alzheimer’s Association International
Conference® 2021 (AAIC®), being held July 26-30, 2021 in Denver,
Colo., and virtually.
The poster presentations include two analyses of patients who
have neurodegenerative disease taking pimavanserin while also
receiving other antidementia medication. One presentation focuses
on safety outcomes while the second describes the impact of an
acetylcholinesterase inhibitor (AChEI) on the pharmacokinetic
profile of pimavanserin in patients with dementia-related
psychosis. The third presentation will discuss a novel screening
tool for psychosis in dementia patients.
AAIC Accepted Presentations:
- Poster Presentation (#57661): Pimavanserin and concomitant
antidementia medication use in patients with neurodegenerative
and/or neurovascular disorders: safety outcomes from pooled
clinical data and the HARMONY study, available to view starting
Monday, July 26. Presenting Author: George Demos, M.D., Acadia
Pharmaceuticals Inc.
- Poster Presentation (#57479): Impact of concomitant
acetylcholinesterase inhibitor use on the pharmacokinetic profile
of pimavanserin in patients with dementia-related psychosis:
modeling data from the Phase 3 HARMONY study, available to view
starting Monday, July 26. Presenting Author: Mona Darwish, Ph.D.,
Acadia Pharmaceuticals Inc.
- Poster Presentation (#57766): Development and Assessment of
a Brief Screening Tool for Psychosis in Dementia, available to
view starting Monday, July 26 Presenting Author: Jeffrey Cummings,
M.D., Sc.D., Joy Chambers-Grundy Professor of Brain Science, Vice
Chair for Research, and Director of the Chambers-Gundy Center for
Transformative Neuroscience, Department of Brain Health, School of
Integrated Health Sciences, University of Nevada Las Vegas
(UNLV).
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 dementia-related psychosis. In
addition, Acadia is developing pimavanserin in other
neuropsychiatric conditions.
About Acadia Pharmaceuticals
Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of
schizophrenia and Rett syndrome, and in early-stage clinical
research we are exploring novel approaches to pain management, and
cognition and neuropsychiatric symptoms in central nervous system
disorders. For more information, visit us at www.acadia-pharm.com
and follow us on LinkedIn and Twitter.
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, 2020 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)
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210714005332/en/
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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