Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the 13th Clinical Tria...
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
scientific presentations highlighting new analyses of pimavanserin
clinical study data in dementia-related psychosis and
neurodegenerative diseases will be shared at the 13th Clinical
Trials on Alzheimer's Disease Conference (CTAD), being held
virtually November 4-7, 2020.
Scientific presentations include those investigating
pimavanserin treatment and its impact on cognition and motor
function in patients with neuropsychiatric symptoms related to
neurodegenerative diseases, including dementia-related psychosis.
Other presentations include a comprehensive literature review of
current use of antipsychotic treatment for dementia-related
psychosis, an analysis of mortality risk and need for long-term
care for patients with dementia-related psychosis versus patients
with dementia only, and assessments of efficacy and safety of
pimavanserin in dementia-related psychosis.
CTAD Accepted Scientific Presentations include:
- Oral Presentation (OC31): Impact of Pimavanserin on
Cognitive Measures in Patients with Neurodegenerative Disease:
Results from 4 Placebo-Controlled Clinical Studies on Friday,
November 6, 10:45 – 11:00 a.m. ET. Presenting author: Clive
Ballard, MBChB, University of Exeter Medical School, Exeter, United
- Oral Presentation (OC17): Relationship Between Pimavanserin
Exposure and Psychosis Relapse in Patients with Dementia-Related
Psychosis: Clinical Results and Modeling Analysis from the Phase 3
HARMONY Study on Thursday, November 5, 10:30 – 10:45 a.m. ET.
Presenting author: Mona Darwish, Acadia Pharmaceuticals Inc.
- Poster Presentation (P75): Impact of Pimavanserin Treatment
on Motor Function in Patients with Neurodegenerative Disease:
Results from 3 Clinical Studies. Presenting author: Daniel
Weintraub, M.D., Departments of Psychiatry and Neurology, Perelman
School of Medicine at the University of Pennsylvania, Philadelphia,
- Poster Presentation (P21): Frequency of
Antipsychotic-Associated Adverse Events with Pimavanserin Treatment
in Patients with Dementia-Related Psychosis. Presenting author:
George Demos, M.D., Acadia Pharmaceuticals Inc.
- Poster Presentation (P71): Comparative Efficacy, Safety,
Tolerability, and Effectiveness of Antipsychotics in the Treatment
of Dementia Related Psychosis (DRP): A Systematic Literature
Review. Presenting author: Ismaeel Yunusa, An-L-lt-Iks,
- Poster Presentation (P69): Mortality Risk and Use of
Long-Term Custodial Care for Patients With Dementia and Psychosis
Versus Patients With Dementia Only: A Longitudinal, Matched Cohort
Analysis of Medicare Claims Data. Presenting author: Nazia
Rashid, Acadia Pharmaceuticals Inc.
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®. Acadia
submitted a supplemental new drug application (sNDA) for
pimavanserin for the treatment of hallucinations and delusions
associated with dementia-related psychosis on June 3, 2020. The FDA
has accepted for filing the sNDA for DRP with a PDUFA date of April
3, 2021. NUPLAZID is not approved for dementia-related psychosis.
In addition, Acadia is developing pimavanserin in other
About Acadia Pharmaceuticals
Acadia is trailblazing breakthroughs in neuroscience to elevate
life through science. 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 commercialize 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, cognition and neuropsychiatric symptoms in central
nervous system disorders. For more information, visit us at
www.acadia-pharm.com and follow us on LinkedIn.
Important Safety Information and Indication for NUPLAZID
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
- Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of
- 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
- 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
- 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
- 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
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please read the full Prescribing Information including Boxed
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Media Contact: Acadia Pharmaceuticals Inc. Eric Endicott (858)
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
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