- Pimavanserin achieved robust statistical
superiority over placebo in time to relapse of dementia-related
psychosis at planned interim efficacy analysis
- Pimavanserin has the potential to be the
first FDA-approved drug for the treatment of dementia-related
psychosis
- Approximately 1.2 million patients in the
United States are diagnosed with dementia-related psychosis
- Conference call and webcast to be held today
at 8:30 a.m. Eastern Time
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
its Phase 3 HARMONY study, a double-blind, placebo-controlled
relapse prevention trial evaluating pimavanserin for the treatment
of dementia-related psychosis, met its primary endpoint,
demonstrating a highly statistically significant longer time to
relapse of psychosis with pimavanserin compared to placebo in a
planned interim efficacy analysis.
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 will now be stopped early
based on pre-specified stopping criteria requiring a one-sided
p-value less than 0.0033 on the study’s primary endpoint.
The Company is planning to meet with the FDA regarding a
supplemental NDA submission in 2020 and the results from the
HARMONY study will be submitted for presentation at upcoming
medical meetings.
The FDA previously granted Breakthrough Therapy Designation for
pimavanserin for the treatment of dementia-related psychosis. No
drug is approved by the FDA for the treatment of dementia-related
psychosis.
“Psychosis adds dramatically to the marked burden that dementia
patients already carry and is one of the most challenging-to-manage
aspects of the disease for caregivers,” said Jeffrey Cummings,
M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center
for Brain Health in Las Vegas. “With no approved treatment options
available today for dementia-related psychosis, the pimavanserin
study results represent a meaningful advance that will potentially
bring us a much needed therapy for this debilitating disease.”
“We are very excited that today’s results bring us one step
closer to the potential of offering patients with dementia-related
psychosis a critically needed treatment option,” said Serge
Stankovic, M.D., M.S.P.H., ACADIA's President. “We look forward to
speaking with the FDA about a supplemental new drug application to
support pimavanserin for the treatment of dementia-related
psychosis. I want to thank all of the patients, their families, and
the investigators for their participation in this important
study.”
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.
Conference Call and Webcast Information
ACADIA will discuss today’s announcement from its Phase 3 trial
of pimavanserin for the treatment of patients with dementia-related
psychosis via conference call and webcast today at 8:30 a.m.
Eastern Time. The conference call can be accessed by dialing
855-638-4820 for participants in the U.S. or Canada and
443-877-4067 for international callers (reference passcode
9785159). A telephone replay of the conference call may be accessed
through September 16, 2019 by dialing 855-859-2056 for callers in
the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 9785159). The conference call will also be
webcast live on ACADIA’s website, www.acadia-pharm.com, in the
investors section and will be archived there until October 9,
2019.
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, 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:
intended activities with respect to the HARMONY study following the
interim analysis, expected timelines with respect to full data from
the HARMONY study and the Company’s planned engagement with the
FDA. 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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version on businesswire.com: https://www.businesswire.com/news/home/20190909005286/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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