- If approved, NUPLAZID would be the first and
only treatment indicated for dementia-related psychosis
- Prescription Drug User Fee Act (PDUFA) date
set for April 3, 2021
- Conference call and webcast to be held today
at 4:30 p.m. Eastern Time
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
the U.S. Food and Drug Administration (FDA) has accepted for filing
its supplemental New Drug Application (sNDA) for NUPLAZID®
(pimavanserin) for the treatment of hallucinations and delusions
associated with dementia-related psychosis (DRP).
“We are pleased that the FDA has accepted our sNDA for filing
and we will be working closely with the FDA to facilitate
completion of the review in a timely manner,” said Steve Davis,
ACADIA’s Chief Executive Officer. “If approved, NUPLAZID would be
the first therapy indicated for the treatment of hallucinations and
delusions associated with dementia-related psychosis. We look
forward to potentially bringing this important treatment
advancement to patients, caregivers and physicians.”
The FDA has assigned a standard review with a PDUFA
(Prescription Drug User Fee Act) action date of April 3, 2021. The
FDA has also informed the company that it has not identified any
potential review issues at this point in their evaluation and at
this time they are not planning to hold an Advisory Committee
meeting.
Dementia is highly prevalent, affecting approximately 8 million
people in the U.S., and is expected to grow as the population ages.
Approximately 30 percent, or 2.4 million people, experience
dementia-related psychosis and only half of them, or 1.2 million,
are diagnosed and treated1,2.
The sNDA is supported by results from the pivotal Phase 3
HARMONY study, which met its primary endpoint, demonstrating that
pimavanserin significantly reduced the risk of relapse of psychosis
by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided
p=0.0023). The sNDA also includes positive efficacy results from
two additional placebo-controlled studies, both of which met their
respective primary endpoints: the Phase 2 (-019) study in patients
with Alzheimer’s disease psychosis and the Phase 3 (-020) study in
patients with Parkinson’s disease psychosis. The sNDA includes a
large safety database from completed and ongoing studies
representing over 1500 patients with neurodegenerative disease.
NUPLAZID was approved in the U.S. in 2016 as the first and only
treatment for hallucinations and delusions associated with
Parkinson’s disease psychosis. Pimavanserin was granted
Breakthrough Therapy Designation by the FDA for the treatment of
hallucinations and delusions associated with DRP in October
2017.
Conference Call and Webcast Information
ACADIA will provide a corporate update via conference call and
webcast today at 4:30 p.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 1486597). A telephone replay of the conference call may be
accessed through July 27, 2020 by dialing 855- 859-2056 for callers
in the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 1486597). 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 August 20,
2020.
About HARMONY
HARMONY was a Phase 3 study designed to evaluate the efficacy
and safety of pimavanserin for the treatment of hallucinations and
delusions associated with dementia-related psychosis across a broad
population of patients with the most common clinically diagnosed
subtypes of dementia including: Alzheimer’s disease, dementia with
Lewy bodies, Parkinson’s disease dementia, vascular dementia, and
frontotemporal dementia spectrum disorders. A total of 392 patients
were enrolled in the study, with an average age of 74.5 years and a
mean Mini-Mental State Examination (MMSE) score of 16.7. The
primary endpoint in the study was time to relapse in the
double-blind period as represented by the Kaplan-Meier curve and
the hazard ratio. Top-line results were presented at the Clinical
Trials on Alzheimer’s Disease (CTAD) Meeting in December 2019.
The HARMONY study included a 12-week open-label stabilization
period during which patients with dementia-related psychosis began
treatment with pimavanserin 34 mg once daily. In the open-label
period, a significant majority (61.8%) of eligible subjects (N=351)
met the sustained treatment response criteria at Week 8 and Week 12
and entered the double-blind period. Following the open-label
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. Pimavanserin met its primary
endpoint and was stopped at the pre-planned interim analysis for
positive efficacy, demonstrating that pimavanserin significantly
reduced the risk of relapse of psychosis by 2.8 fold compared to
placebo (hazard ratio = 0.353; one-sided p=0.0023).
Pimavanserin was well-tolerated over the entire nine-month study
duration, and pimavanserin treatment was not associated with a
decline in cognition, as measured by the MMSE score, or the onset
or worsening of extrapyramidal symptoms, as measured by the
Extrapyramidal Symptom Rating Scale A (ESRS-A) score, compared to
placebo. In the double-blind period, low rates of adverse events
were observed, 41.0% of patients on pimavanserin and 36.6% on
placebo. Discontinuations in the double-blind period due to adverse
events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates
of serious adverse events were also low, 4.8% in the pimavanserin
group and 3.6% in the placebo group. One death was reported in the
open-label period and one death was reported in the pimavanserin
group during the double-blind period. Investigators determined
neither death was related to the study drug.
About Dementia-Related Psychosis
Approximately 8 million people in the United States are living
with dementia, a condition with a core feature of declining
cognition (changes in memory, decision-making abilities, language,
etc.) resulting in functional impairment. Dementia is a
manifestation of an underlying condition which is often progressive
and neurodegenerative in nature.3 In addition to cognitive decline,
dementing illnesses almost universally lead to neuropsychiatric
symptoms, including hallucinations, delusions, and changes in
behavior.
It is estimated that 2.4 million Americans (or 30% of people
with dementia) experience dementia-related hallucinations and
delusions.1,2 These symptoms may be frequent and severe and may
recur over time. A hallucination is defined as a perception-like
experience that occurs without an external stimulus and is sensory
(seen, heard, felt, tasted, sensed) in nature. A delusion is
defined as a false, fixed belief that is resolutely held despite
evidence to the contrary. Dementia-related psychosis occurs in many
types of dementia, including Alzheimer’s disease, dementia with
Lewy bodies, Parkinson’s disease dementia, vascular dementia, and
frontotemporal dementia. Serious consequences have been associated
with psychosis in patients with dementia, such as repeated hospital
admissions, increased likelihood of nursing home placement, faster
progression of dementia, and increased risk of morbidity and
mortality.4
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 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’s development efforts are
focused on pimavanserin for additional neuropsychiatric conditions,
trofinetide for Rett syndrome, and an early-stage muscarinic
receptor program. 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
pimavanserin as a potential treatment for the hallucinations and
delusions associated with dementia-related psychosis, the expected
growth in patients with dementia and other statements that are not
historical facts. 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. 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)
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.
- 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.
- Adverse Reactions: The 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.
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.
References
1Plassman BL, et al. Prevalence of dementia in the United
States: The Aging Demographics, and Memory study.
Neuroepidemiology. 2007;29(1-2):125-132. 22017 Alzheimer’s Disease
Facts and Figures and ACADIA market research. 3Dementia. (2019,
September 19). Retrieved from
https://www.who.int/news-room/fact-sheets/detail/dementia. 4Connors
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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Media Contact: ACADIA Pharmaceuticals Inc. Eric Endicott (858)
914-7161 media@acadia-pharm.com
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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