ACADIA Pharmaceuticals Announces Late-Breaking Oral Presentation of the Phase 3 HARMONY Study of Pimavanserin in Dementia-Rel...
October 03 2019 - 4:55PM
Business Wire
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
the presentation of the results from the Phase 3 HARMONY study of
pimavanserin in dementia-related psychosis has been accepted for a
late-breaking oral communication at the upcoming 12th Clinical
Trials on Alzheimer’s Disease (CTAD) Meeting, December 4-7, 2019 in
San Diego, California.
Late-Breaking Oral
Presentation
- Presentation: LB1
- Abstract Title: HARMONY Relapse-Prevention Study: Pimavanserin
Significantly Prolongs Time to Relapse of Dementia-Related
Psychosis
- Presentation Date: Wednesday, December 4, 2019
- Presentation Time: 5:45 p.m. Pacific Time
On September 9, 2019, ACADIA announced that the Phase 3 HARMONY
study, a double-blind, placebo-controlled relapse prevention trial
evaluating an investigational use of pimavanserin for the treatment
of dementia-related psychosis, met its primary endpoint. In the
study pimavanserin demonstrated a highly statistically significant
longer time to relapse of psychosis compared to placebo. Upon the
recommendation of the study’s independent data monitoring
committee, which met to review the data from the planned interim
efficacy analysis, the study was stopped early based on
demonstration of efficacy. The pre-specified stopping criteria at
the planned interim efficacy analysis required a one-sided p-value
less than 0.0033 on the study’s primary endpoint.
About the HARMONY Study
HARMONY is a Phase 3 study designed to evaluate the efficacy and
safety of pimavanserin for the treatment of delusions and
hallucinations associated with dementia-related psychosis across a
broad population of patients with the most common subtypes of
dementia including: Alzheimer’s disease, dementia with Lewy bodies,
Parkinson’s disease dementia, vascular dementia, and frontotemporal
dementia spectrum disorders.
The HARMONY study included a 12-week open-label stabilization
period during which patients with dementia-related psychosis were
treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg
once daily was allowed if clinically justified within the first
four weeks. Following the 12-week stabilization period, patients
who met pre-specified criteria for treatment response were then
randomized into the double-blind period of the study to continue
their pimavanserin dose (34 mg or 20 mg per day) or switched to
placebo and followed for up to 26 weeks or until a relapse of
psychosis occurred. The primary endpoint in the study was time to
relapse in the double-blind period.
Relapse (significant worsening of dementia-related psychosis
after prior stabilization) was defined in the study by one or more
of the following: hospitalization due to dementia-related
psychosis, significant deterioration of dementia-related symptoms
on clinical scales, withdrawal from the study due to lack of
efficacy, or the use of an off-label antipsychotic medication for
the treatment of dementia-related delusions and/or hallucinations.
All potential relapses and discontinuations in the double-blind
portion of the study were adjudicated by an independent
adjudication committee to determine if protocol defined relapse
criteria were met.
About Dementia-Related Psychosis
Around 8 million people in the United States are living with
dementia and studies suggest that approximately 30% of dementia
patients, or 2.4 million people, have psychosis, commonly
consisting of delusions and hallucinations1,2. Dementia-related
psychosis includes psychosis in Alzheimer’s disease, dementia with
Lewy bodies, Parkinson’s disease dementia, vascular dementia, and
frontotemporal dementia. Serious consequences have been associated
with severe or persistent psychosis in patients with dementia such
as repeated hospital admissions, increased likelihood of nursing
home placement, progression of dementia, and increased risk of
morbidity and mortality3.
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 as a treatment for
dementia-related psychosis 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, 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.
References
1 2017 Alzheimer’s Disease Facts and Figures and ACADIA market
research 2Plassman BL, et al. Prevalence of dementia in the United
States: the Aging Demographics, and Memory study.
Neuroepidemiology. 2007;29(1-2):125-132. 3Connors MH et al. Am J
Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry
2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11).
Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al.
Neurology 1994;44(12).
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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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