Acadia Pharmaceuticals Announces Plan for a Resubmission of its Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin)
21 December 2021 - 8:05AM
Business Wire
- Acadia plans to resubmit its sNDA in the
first quarter of 2022
- Conference call and webcast to be held today
at 4:30 p.m. Eastern Time
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that
it plans to resubmit its supplemental New Drug Application (sNDA)
for pimavanserin for the treatment of hallucinations and delusions
associated with dementia focused on Alzheimer’s disease psychosis
(ADP). Resubmission of the sNDA to the U.S. Food and Drug
Administration (FDA) is planned for the first quarter of 2022.
“Following our recent meetings with the FDA, we plan to resubmit
our sNDA for pimavanserin, narrowing the proposed indication from
dementia-related psychosis to Alzheimer’s disease psychosis,” said
Steve Davis, Chief Executive Officer. “Our resubmission will
include new analyses of existing clinical study data supporting the
treatment of hallucinations and delusions associated with
Alzheimer’s disease. We are aware there are challenges to
overcoming our complete response letter, but are pleased with the
high level of engagement from the FDA over the last three meetings
and their willingness to review our resubmission, allowing us to
make our case that pimavanserin should be the first drug approved
to treat Alzheimer’s disease psychosis.”
The resubmission is intended to demonstrate pimavanserin’s
clinically meaningful benefit in ADP patients, without worsening of
cognition or motor function in this elderly population. The
resubmission will include data from two positive,
placebo-controlled studies that prospectively met their primary
endpoints: the pivotal Phase 3 HARMONY study1 and the -019 study2.
Additional analyses from HARMONY and -019 will also be provided
that validate the primary conclusions from each study and address
the concerns raised in the FDA’s complete response letter.
Conference Call and Webcast Information Acadia will discuss this
regulatory update regarding the resubmission of the sNDA for
pimavanserin for the treatment of ADP 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 3072268). A telephone replay of the conference call may be
accessed through January 4, 2022 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 3072268). The conference call will also
be webcast live on Acadia’s website, www.acadia-pharm.com, in the
investors section and archived until January 17, 2022.
About Alzheimer’s Disease Psychosis According to the Alzheimer’s
Association, over six million people in the United States are
living with Alzheimer’s disease3. Studies suggest that 25 to 50
percent of patients diagnosed with Alzheimer’s disease have
psychosis, commonly consisting of hallucinations and delusions4.
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. 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 mortality5. There
is no FDA approved drug for the treatment of Alzheimer’s disease
psychosis.
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®.
NUPLAZID is not approved for dementia-related psychosis. In
addition, Acadia is developing pimavanserin in other
neuropsychiatric conditions.
About Acadia Pharmaceuticals Acadia is advancing breakthroughs
in neuroscience to elevate life. For more than 25 years we have
been working at the forefront of healthcare to bring vital
solutions to people who need them most. We developed and
commercialized the first and only approved therapy for
hallucinations and delusions associated with Parkinson’s disease
psychosis. Our late-stage development efforts are focused on
treating psychosis in patients with dementia, the negative symptoms
of schizophrenia and Rett syndrome. Our early-stage development
efforts are focused on novel approaches to pain management,
cognition and neuropsychiatric symptoms in central nervous system
disorders. For more information, visit us at www.acadia-pharm.com
and follow us on LinkedIn and Twitter.
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.
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 regarding the timing of future events. 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, 2020 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.
References 1Tariot PN, et al. N Engl J Med. 2021;
385(4):309-319. 2Ballard C, et al. Lancet Neurol.
2018;17(3):213-222. Ballard C, et al. J Prev Alzheimers Dis.
2019;6(1):27-33. 32021 Alzheimer’s Disease Facts and Figures and
Acadia market research. 4Plassman BL, et al. Prevalence of Dementia
in the United States: The Aging Demographics, and Memory study.
Neuroepidemiology. 2007;29(1-2):125-132. 5Connors 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. Deb Kazenelson
818-395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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