ACADIA Pharmaceuticals to Present Pimavanserin Clinical Data at the 2020 American Society of Clinical Psychopharmacology Virt...
May 21 2020 - 9:00AM
Business Wire
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
multiple scientific presentations and abstracts evaluating
pimavanserin in clinical studies for the treatment of various
central nervous system (CNS) disorders will be highlighted at the
2020 American Society of Clinical Psychopharmacology (ASCP) Virtual
Annual Meeting on May 29-30, 2020.
“Our research presentations at ASCP underscore the potential
clinical utility of pimavanserin in serious CNS disorders,” said
Serge Stankovic, M.D., M.S.P.H., ACADIA's President. “We look
forward to sharing data from our pivotal studies in negative
symptoms of schizophrenia and major depressive disorder where
pimavanserin has demonstrated the potential to be an important
treatment option for patients, as well as new long-term safety and
tolerability data of NUPLAZID® in Parkinson’s disease
psychosis.”
ASCP Accepted Scientific Presentations include:
Negative Symptoms of
Schizophrenia
- Pharmaceutical Pipeline Oral Presentation: ADVANCE: Phase 2,
Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive
Pimavanserin in Patients with Negative Symptoms of Schizophrenia on
Saturday, May 30, 2020, 4:55 p.m. - 5:05 p.m. Eastern Time.
- Poster Presentation: ADVANCE: Phase 2, Randomized,
Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin
in Patients with Negative Symptoms of Schizophrenia on Saturday,
May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.
Depression
- Poster Presentation: Effect of Adjunctive Pimavanserin on
Suicidality in Patients with Major Depressive Disorder: Secondary
Analysis from CLARITY on Friday, May 29, 2020, 12:30 p.m. - 2:00
p.m. Eastern Time.
- Poster Presentation: Effect of Adjunctive Pimavanserin on
Insomnia and Function in Patients with Major Depressive Disorder:
Secondary Analysis from CLARITY on Saturday, May 30, 2020, 12:45
p.m. - 2:15 p.m. Eastern Time.
- Poster Presentation: Pimavanserin for the Treatment of Comorbid
Depression in Patients with Parkinson’s Disease on Friday, May 29,
2020, 12:30 p.m. - 2:00 p.m. Eastern Time.
Parkinson’s Disease Psychosis
- Poster Presentation: Long-Term Evaluation of Open-Label
Pimavanserin Safety and Tolerability in Parkinson’s Disease
Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern
Time.
- Poster Presentation: Improvement and Durability in SAPS-PD
Assessment over 10 Weeks of Pimavanserin Treatment for Parkinson’s
Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m.
Eastern 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, major depressive
disorder or depression in patients with Parkinson’s disease.
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, major depressive
disorder, the negative symptoms of schizophrenia, 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 as adjunctive treatment for
major depressive disorder, the negative symptoms of schizophrenia
or other 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, 2019 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/20200521005146/en/
Media Contact: ACADIA Pharmaceuticals Inc. Stephanie Fagan (858)
212-0534 media@acadia-pharm.com
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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