Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the 13th Clinical Trials on Alzheimer's Disease (CTAD) Conference
Acadia Pharmaceuticals (Nasdaq: ACAD) will present new analyses of pimavanserin clinical data for dementia-related psychosis at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD) from November 4-7, 2020. Presentations will cover the impact of pimavanserin on cognition and motor function in neurodegenerative conditions, alongside safety assessments. Notable presentations include findings from the Phase 3 HARMONY Study and a literature review on antipsychotic treatments for dementia-related psychosis. The FDA accepted Acadia's supplemental application for pimavanserin in this indication, with a PDUFA date set for April 3, 2021.
- FDA accepted supplemental new drug application (sNDA) for pimavanserin for dementia-related psychosis.
- Upcoming data presentations at the CTAD may enhance visibility and interest in pimavanserin.
- Pimavanserin is not approved for dementia-related psychosis, limiting current market potential.
- Concerns regarding increased mortality risks in elderly dementia patients treated with antipsychotics.
SAN DIEGO--(BUSINESS WIRE)--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 Presentations:
- 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 Kingdom.
- 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 Presentations:
- 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, PA, USA.
- 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, Inc.
- 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.
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®. 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 neuropsychiatric conditions.
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 (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.
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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.
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Adverse Reactions: The common adverse reactions (≥
2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs2% ), nausea (7% vs4% ), confusional state (6% vs3% ), hallucination (5% vs3% ), constipation (4% vs3% ), 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.
