- Patients previously treated with 34 mg showed
sustained response
- Patients on investigational doses and placebo
demonstrated symptom improvement when switched to 34 mg dose during
OLE
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced
publication of open-label extension (OLE) data from patients
experiencing hallucinations and delusions associated with
Parkinson’s disease psychosis (PDP) who had previously completed
one of three, six-week, double-blind, placebo-controlled
studies.
The OLE efficacy analysis showed that patients previously on
NUPLAZID 34 mg had a sustained efficacy response from Week 6
through Week 10, and that patients who had been treated with
investigational doses of 8.5 mg and 17 mg or placebo also showed an
improvement in the symptoms of psychosis when switched to NUPLAZID
34 mg over the 4 weeks of the OLE. The completed study was
published online and in the June issue of Parkinsonism and Related
Disorders. Full text of the paper can be found at:
https://www.prdjournal.com/article/S1353-8020(21)00145-0/fulltext.
“Results from a multi-center OLE study, across 14 countries,
demonstrate the extended durability of efficacy of NUPLAZID for
treating hallucinations and delusions associated with PDP, in
addition to reinforcing the efficacy seen in the original pivotal
trial using the 34 mg dose,” said Stuart Isaacson, M.D., Director,
Parkinson’s Disease and Movement Disorders Center of Boca Raton.
“As a physician, having NUPLAZID, an FDA-approved and proven
therapy to treat these debilitating symptoms without impairing
motor function, represents a major step forward. NUPLAZID is a
critical first-line therapy for our patients living with PDP, and
their caregivers.”
Importantly, non-motor symptoms of Parkinson’s disease,
including hallucinations and delusions, can be more troublesome
than motor symptoms.1 Hallucinations and delusions can also worsen
over time, making it difficult for patients to know whether or not
what they are experiencing is real.2,3
“We’re pleased to have additional published data supporting the
efficacy of NUPLAZID, as approximately 50 percent of people living
with Parkinson’s may experience hallucinations and delusions during
the course of their disease,” said Ponni Subbiah, M.D., M.P.H.,
Senior Vice President, Global Head of Medical Affairs and Chief
Medical Officer at Acadia. “These symptoms can have a significant
impact on both patients and their families, negatively impacting
their quality of life and causing severe emotional distress.”
About the Open-Label Extension (OLE) Study
The OLE study was designed to evaluate the long-term safety of
NUPLAZID. The publication includes an analysis of the efficacy
results from the initial four weeks of the OLE study and included
patients who had previously completed one of three, six-week,
double-blind, placebo-controlled studies. All patients in the OLE
were treated with NUPLAZID 34 mg. Changes in PDP symptoms were
evaluated according to the Scale for the Assessment of Positive
Symptoms (SAPS): the SAPS-PD and the Hallucinations + Delusions
domains, Clinical Global Impression (CGI) Improvement and Severity
scales and Caregiver Burden Scale (CBS).
Of 459 patients enrolled in the OLE, 424 (92.4%) had a Week 4
efficacy assessment. Overall, the response to NUPLAZID 34 mg that
was observed in the SAPS-PD scores during the initial six weeks
persisted through Week 4 of the OLE (mean change from OLE baseline
(standard deviation) to OLE Week 4 for the SAPS-PD of -0.8 (5.6)),
while scores among patients switched from placebo to NUPLAZID 34 mg
improved (with a mean change from OLE baseline to OLE Week 4 in the
SAPS-PD of -2.9 (5.6)). For patients treated with pimavanserin 8.5
mg or 17 mg investigational doses in the previous studies, further
improvement was observed during the OLE with NUPLAZID 34 mg.
During the initial four weeks of the OLE study, adverse events
(AEs) were reported by 215 (46.8%) patients. Twenty-seven (5.9%)
patients had an AE that resulted in discontinuation of the study or
study drug. The majority of AEs were of mild or moderate intensity;
seven (1.5%) patients had serious AEs. The most common AEs were
fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%),
insomnia (2.4%), and peripheral edema (2.2%). Complete safety
findings from the OLE study over 9 years of study follow-up were
previously published by Ballard CG, et al.4
About Parkinson’s Disease and Parkinson’s Disease Psychosis
Parkinson’s disease is a progressive nervous system disorder
that affects about one million people in the United States.5,6 The
signs and symptoms can vary with people experiencing both motor
symptoms and non-motor symptoms such as hallucinations (seeing,
hearing, or experiencing things that others don’t) and delusions
(false beliefs).3,7 Physicians may refer to these
Parkinson’s-related hallucinations and delusions as Parkinson’s
disease psychosis (PDP).3 Around 50 percent of people living with
Parkinson's may experience hallucinations or delusions during the
course of their disease.7 Non-motor symptoms, as a whole, can be
more troublesome than motor symptoms, in terms of quality of life.1
PDP may add to the burden of caring for a loved one with
Parkinson’s disease.8,9
About NUPLAZID® (pimavanserin)
NUPLAZID 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 trailblazing 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 dementia-related psychosis, negative symptoms of
schizophrenia and Rett syndrome, and in early-stage clinical
research we are exploring novel approaches to pain management, and
cognition and neuropsychiatric symptoms in central nervous system
disorders. For more information, visit us at www.acadia-pharm.com
and follow us on LinkedIn.
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.
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.
1 Martinez-Martin P, Rodriguez-Blazquez C, et al. The Impact of
Non-Motor Symptoms on Health Related Quality of Life of Patients
with Parkinson’s Disease. Mov Disord. 2011;26(3):399-406.
2 Goetz, CG, Fan, W, Leurgans, S, et al. The malignant course of
“benign hallucinations” in Parkinson disease. Archives of
neurology. 2006;63(5), 713–716
3 Ravina B, Marder K, Fernandez HH, et al. Diagnostic criteria
for psychosis in Parkinson’s disease: report of an NINDS, NIMH work
group. Mov Disord. 2007 Jun 15;22(8):1061-8.
4 Ballard CG, Kreitzman DL, Isaacson S, et al. Long-term
evaluation of open-label pimavanserin safety and tolerability in
Parkinson's disease psychosis. Parkinsonism Relat Disord.
2020;77:100-106.
5 Parkinson’s Disease Foundation. What is Parkinson’s disease?
Retrieved from https://www.pdf.org/en/about_pd. Accessed November
2014.
6 Postuma, RB, et al. MDS Clinical Diagnostic Criteria for
Parkinson’s Disease. Mov Disorders. 2015; 30(12): 1591-1599
7 Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year
population-based study of psychosis in Parkinson’s disease. Arch
Neurol. 2010;67:996-1001.
8 Schrag A, Hovris A, et al. Caregiver-burden in parkinson's
disease is closely associated with psychiatric symptoms, falls, and
disability. Parkonism and Related Disorders. 2006;12:35-41
9 Aarsland D, Bronnick K, Ehrt U. et al. Neuropsychiatric
symptoms in patients with Parkinson's disease and dementia:
frequency, profile and associated care giver stress. J Neurol
Neurosurg Psychiatry. 2007;78:36-42.
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version on businesswire.com: https://www.businesswire.com/news/home/20210603005317/en/
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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