Two Independent Data Sets Confirm NUPLAZID Is Well-Tolerated and
Efficacious in Treating Hallucinations and Delusions Associated with
Parkinson’s Disease Psychosis
SAN DIEGO--(BUSINESS WIRE)--Apr. 27, 2018--
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system (CNS)
disorders, today announced poster presentations of clinical experience
data from two studies of NUPLAZID® (pimavanserin) in
Parkinson’s disease psychosis (PD Psychosis) at the American Academy of
Neurology (AAN) Annual Meeting in Los Angeles.
Clinical Experience with Pimavanserin for Treatment of Parkinson’s
Vanderbilt University Medical Center performed a retrospective chart
review of patients treated with NUPLAZID. The objective of the study was
to review their prescribing patterns and clinical experiences with
NUPLAZID. In this study, the researchers identified a total of 102
patients who were prescribed NUPLAZID between May 2016 and March 2018.
Eighty eight of these patients began treatment with NUPLAZID and 14
patients never started treatment. About two-thirds of patients had tried
and failed prior antipsychotic therapy. Data from the study show:
>70% of all patients treated with NUPLAZID reported clinical
improvement, while 88% of patients treated longer than four weeks
67% of patients have remained on NUPLAZID for an average of 10+ months.
Only 11% of patients were unable to tolerate NUPLAZID due to adverse
NUPLAZID was effective in both treatment naïve and prior antipsychotic
For those who failed NUPLAZID, improvement with a subsequent
antipsychotic was uncommon.
There was no increase in mortality detected in users of NUPLAZID.
6 of the 88 patients treated with NUPLAZID died (compared to 5 out
of 14 in the group that never started NUPLAZID).
“This retrospective chart review provides relevant clinical experience
data on treatment patterns in a Parkinson’s disease psychosis cohort,”
said Daniel Claassen, MD, Associate Professor of Neurology, Vanderbilt
University Medical Center. “At about ten months of follow-up, we see
that two-thirds of patients have noted a favorable clinical response to
NUPLAZID. We look forward to continuing our studies of how to treat
psychosis in Parkinson’s disease, as we assess treatment strategies for
this debilitating symptom."
Pimavanserin Use in a Movement Disorders Clinic: a Single Center
Researchers from the
Parkinson’s Disease and Movement Disorders Center at Henry Ford Hospital
assessed NUPLAZID’s clinical use by retrospective chart review and
telephone interviews with patients and caregivers. Information on
demographics, psychotic features, sleep, and adverse events was
collected. This assessment of real-life experience in 16 patients
diagnosed with PD Psychosis and taking NUPLAZID showed that NUPLAZID was
well-tolerated and improved symptoms in most patients. Data from this
65% reported improvement of hallucinations with NUPLAZID.
Six of the nine patients originally prescribed an earlier generation
antipsychotic (either quetiapine or olanzapine) were able to
discontinue those drugs following NUPLAZID initiation and remained on
No major side effects were reported.
“Our study was based on real-life experience and shows that NUPLAZID is
a beneficial and well-tolerated treatment for PD Psychosis,” said Neepa
Patel, MD, Movement Disorder Specialist at Henry Ford Hospital in West
About Parkinson’s Disease Psychosis
According to the
Parkinson’s Foundation, about one million people in the United States
and from four to six million people worldwide suffer from Parkinson’s
disease. More than 50 percent of people with Parkinson’s will experience
symptoms of psychosis over the course of their disease. PD Psychosis is
characterized by hallucinations and delusions, is associated with
significant caregiver burden, and is a major reason for nursing home
placement among Parkinson’s patients.
About NUPLAZID® (pimavanserin)
is the first FDA-approved treatment for hallucinations and delusions
associated with Parkinson’s disease psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist preferentially
targeting 5-HT2A receptors that are thought to play an
important role in Parkinson’s disease psychosis. NUPLAZID is an oral
medicine taken once a day with a recommended dose of 34 mg (two 17-mg
tablets). ACADIA discovered this new chemical entity and holds worldwide
rights to develop and commercialize NUPLAZID.
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 maintains a website at www.acadia-pharm.com
to which we regularly post copies of our press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
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 benefits to be derived from NUPLAZID and to any future
studies with NUPLAZID. 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 discovery, 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, 2017 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) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
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.
NUPLAZID is an atypical antipsychotic indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
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
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: Strong CYP3A4 inhibitors (eg, ketoconazole)
increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.
Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced
efficacy. Increase in NUPLAZID dosage may be needed.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and
should therefore be used in pregnancy only if the potential benefit
justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in
Dosage and Administration: Recommended dose: 34 mg per day, taken orally
as two 17-mg tablets once daily, without titration.
For additional Important Safety Information, including boxed warning,
please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.