ACADIA Pharmaceuticals to Present New Clinical Data and Outcomes Research at Upcoming Scientific Meetings
September 19 2019 - 9:00AM
Business Wire
— New
data presented at the International Congress of Parkinson’s Disease
and Movement Disorders will highlight treatment benefit of
pimavanserin in patients with comorbid Parkinson’s disease and
depression
— New
data presented at the Psych Congress will highlight improvement on
sexual functioning observed in patients treated with adjunctive
pimavanserin for major depressive disorder
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced it
will present several scientific posters at the upcoming
International Congress of Parkinson’s Disease and Movement
Disorders® on September 22-26, 2019 in Nice, France and at the
annual Psych Congress on October 3-6, 2019 in San Diego,
California.
Scientific poster presentations will highlight ACADIA’s clinical
and real-world research in central nervous system disorders with
significant unmet need, including Parkinson’s disease and
Parkinson’s disease psychosis, dementia-related psychosis, and
major depressive disorder.
Scientific Presentations at the MDS Congress include:
- Poster Number 163: Open-Label Study of Pimavanserin in Patients
With Comorbid Parkinson’s Disease and Depression presented on
September 23, 2019, 1:45 – 3:15 p.m. CEST.
- Poster Number 129: Use of Off-Label Antipsychotics Among U.S.
Long-Term Care Residents With Parkinson’s Disease Psychosis
presented on September 23, 2019, 1:45 – 3:15 p.m. CEST.
- Poster Number 204: Evaluating the Off-Label Use of
Antipsychotics in Parkinson’s Disease Psychosis Patients Within
Large National U.S. Healthcare Databases presented on September 23,
2019, 1:45 – 3:15 p.m. CEST.
- Poster Number 756: Healthcare Resource Utilization and Costs of
Parkinson’s Disease Dementia With Psychosis in the U.S. Medicare
Population presented on September 23, 2019, 1:45 – 3:15 p.m.
CEST.
- Poster Number 1836: Comparison of Dementia Patients With and
Without Parkinson’s Disease Before Dementia-Related Psychosis
Occurs: An Administrative Claims Data Analysis presented on
September 25, 2019, 1:15 – 2:45 p.m. CEST.
Scientific Presentations at the Psych Congress
include:
- Poster Number 137: Improvement of Sexual Function Observed
During Treatment of Major Depressive Disorder With Adjunctive
Pimavanserin presented on October 4, 2019, 1:30 – 3:00 p.m. Pacific
Time.
- Poster Number 146: Open-Label Study of Pimavanserin in Patients
With Comorbid Parkinson’s Disease and Depression presented on
October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
- Poster Number 147: A Post Hoc Analysis Evaluating the Impact of
a Reduction in Psychosis on the Severity of Agitation and
Aggression in Patients With Alzheimer’s Disease presented on
October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
- Poster Number 211: CLARITY: A Phase 2 Double-blind,
Placebo-controlled Study to Evaluate the Efficacy and Safety of
Adjunctive Pimavanserin in Major Depressive Disorder presented on
October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
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 psychosis,
schizophrenia, depression, and other neuropsychiatric disorders. In
vitro, pimavanserin demonstrated no appreciable binding affinity
for dopamine (including D2), histamine, muscarinic, or adrenergic
receptors. ACADIA is evaluating pimavanserin in an extensive
clinical development program across multiple indications with
significant unmet need including dementia-related psychosis,
adjunctive major depressive disorder, and the negative symptoms of
schizophrenia. 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, schizophrenia or major depressive
disorder.
About ACADIA Pharmaceuticals
ACADIA 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 commercialized the first and only medicine approved
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. ACADIA also has ongoing clinical
development efforts in additional areas with significant unmet
need, including dementia-related psychosis, schizophrenia, major
depressive disorder, and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
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 related to:
the potential benefits of pimavanserin for central nervous system
disorders as well as the potential results of clinical trials of
pimavanserin in other indications. 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, 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, 2018 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 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.
- 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 or moderate CYP3A4 inducers
reduces NUPLAZID exposure. Avoid concomitant use of strong or
moderate CYP3A4 inducers with NUPLAZID.
Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.
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 see the full Prescribing Information including Boxed
WARNING for NUPLAZID.
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version on businesswire.com: https://www.businesswire.com/news/home/20190919005183/en/
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
Media Contact: ACADIA Pharmaceuticals Inc. Maurissa Messier
(858) 768-6068 media@acadia-pharm.com
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