ACADIA Pharmaceuticals Presents New Data on PD Patients Treated with Pimavanserin for Depression at the 2019 International Co...
September 23 2019 - 9:00AM
Business Wire
- Pimavanserin as monotherapy or adjunct to
SSRI/SNRI therapies significantly improved depression symptoms for
Parkinson’s patients
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced
positive results from an 8-week, open-label, single-arm Phase 2
study evaluating an investigational use and safety of pimavanserin
as a monotherapy or adjunct to selective serotonin reuptake
inhibitor (SSRI) or selective norepinephrine reuptake inhibitor
(SNRI) therapy for Parkinson’s disease (PD) patients with
depressive symptoms. These results were presented today during a
poster session at the 2019 International Congress of Parkinson’s
Disease and Movement Disorders® (MDS) in Nice, France.
Data reported in the study poster, “Open-Label Study of
Pimavanserin in Patients With Comorbid Parkinson’s Disease and
Depression” showed that PD patients (n=47) treated with
pimavanserin for depressive symptoms had significant improvement on
the primary endpoint, the 17-item Hamilton Depression Rating Scale
(HAMD-17) total score from the change in baseline to week 8
(p<0.0001), with significant improvement seen as early as week 2
(p<0.0001). Improvement of ≥50% on the HAMD-17 total score was
observed in 60.0% of patients at week 8, with 44.4% of patients
reaching remission (HAMD-17 ≤7).
“Mood disorders, particularly depression, occur in approximately
50% of patients with PD, and depressive symptoms in patients with
PD are associated with diminished quality of life, greater
disability, and faster progression of physical symptoms,” said Gus
Alva, M.D., Founder and Medical Director of ATP Clinical Research
and co-author of the study. “Results of this open-label study
suggest that pimavanserin may be a potential treatment to be
further investigated for depression associated with Parkinson’s
disease.”
Additional results from this study showed that PD patients
treated with pimavanserin for depression also demonstrated
improvement on multiple secondary endpoints compared to baseline,
including the Clinical Global Impression-Severity scale (baseline
to week 8, p<0.0001), Clinical Global Impression-Improvement
scores (decreased from 2.5 at week 2 to 2.0 at week 8),
SCOPA-night-time sleep and SCOPA-day-time sleep scales showed
significant improvements in all three measures by week 4 that were
maintained through week 8, in addition to SCOPA-Global Sleep
Quality scale, which improved significantly (baseline to week 8,
p<0.0001). In the study, pimavanserin was well tolerated and
treatment emergent adverse events (TEAE) reported were consistent
with other studies of patients treated with pimavanserin. TEAE
reported included: falls (8.5%), nausea (6.4%), diarrhoea (4.3%),
oedema (4.3%), skin abrasion (4.3%), and urinary tract infection
(4%).
“We are pleased with the exploratory study results which show a
positive treatment effect with pimavanserin for depression in
patients with Parkinson’s disease,” said Serge Stankovic, M.D.,
M.S.P.H., ACADIA's President. “These results are also consistent to
those observed in our Phase 2 study with pimavanserin as an
adjunctive treatment for patients with an inadequate response to
existing first-line SSRI/SNRI therapy for major depressive
disorder. We are committed to continued research for pimavanserin
to address unmet medical needs in central nervous system disorders,
including our ongoing Phase 3 clinical program in major depressive
disorder.”
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, major depressive
disorder or depression in patients with Parkinson’s disease.
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, schizophrenia, major
depressive disorder, 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:
the potential benefits of pimavanserin for central nervous system
disorders as well as the potential results of clinical trials of
pimavanserin in other indications. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190923005157/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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