- Pimavanserin as an adjunctive treatment for
patients with MDD showed significant overall improvement in HAMD-17
total score compared to placebo
- Phase 3 CLARITY program initiated in April
2019
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), announced today that
positive results from the Phase 2 CLARITY study evaluating
pimavanserin as adjunctive treatment in patients with major
depressive disorder (MDD) have been published online by The Journal
of Clinical Psychiatry, the official journal of the American
Society of Clinical Psychopharmacology (ASCP). In this 10-week,
randomized, double-blind, placebo-controlled study (n=207),
pimavanserin met the overall primary endpoint of the study by
significantly reducing the 17-item Hamilton Depression Rating Scale
(HAMD-17) total score compared to placebo (p=0.039). In the
parallel design portion (Stage 1) of this two-stage sequential
parallel comparison design (SPCD) study, adding pimavanserin to
first-line SSRI or SNRI therapy also significantly reduced HAMD-17
scores compared to placebo (p=0.0003). On the key secondary
endpoint, pimavanserin also demonstrated statistically significant
reductions compared to placebo in the Sheehan Disability Scale
(SDS) score (p=0.004).
The study published today, “A Phase 2, Randomized, Double-Blind,
Placebo-Controlled Study of Adjunctive Pimavanserin in Patients
with Major Depressive Disorder and an Inadequate Response to
Therapy (CLARITY),” also included positive overall results observed
for additional secondary study endpoints with nominal p-values
including: Clinical Global Impression-Severity (p=0.0084), Clinical
Global Impression-Improvement (p=0.0289), Karolinska Sleepiness
Scale (p=0.0205), Massachusetts General Hospital Sexual Functioning
Index (p=0.0003), and Barratt Impulsiveness Scale (p=0.0075).
Pimavanserin was well-tolerated in the study and the most common
adverse events reported in the pimavanserin group were dry mouth,
nausea, and headache all with frequency of less than 10%.
“Today, the standard of care in MDD is to start patients on SSRI
or SNRI therapies. However, a majority of patients do not
adequately respond to these initial treatments and are prescribed
an adjunctive therapy to manage their symptoms,” said Professor
Maurizio Fava, M.D., Executive Vice Chair, Department of
Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean
for Clinical & Translational Research, Harvard Medical School.
“Results from this study suggest pimavanserin could be an important
new adjunctive treatment for MDD patients who continue to
experience significant depression with their initial therapy.”
“Based on these positive Phase 2 results, we initiated our Phase
3 CLARITY program earlier this year to further evaluate
pimavanserin as an adjunctive treatment option for MDD. At least
one additional positive trial out of the two ongoing Phase 3
studies, together with our Phase 2 study, will serve as the basis
for an sNDA submission,” said Serge Stankovic, M.D., M.S.P.H.,
ACADIA's President.
About the Phase 2 CLARITY Study
The study was conducted in collaboration with the MGH Clinical
Trials Network & Institute (CTNI) and randomized 207 adult
patients with a confirmed inadequate response to existing
first-line selective serotonin reuptake inhibitor (SSRI) or
serotonin norepinephrine reuptake inhibitor (SNRI) therapy for MDD
across 27 U.S. clinical research centers.
Consistent with the SPCD design, the study was conducted in two,
five-week sequential stages. Eligible subjects continued receiving
their SSRI or SNRI antidepressant at a stable dose for the duration
of the study. Patients were randomly assigned (1:3) to pimavanserin
34 mg/day or placebo in Stage 1. Placebo non-responders in Stage 1
(defined as HAMD-17 total score >14 and a percent-reduction from
baseline in HAMD-17 total score of <50% at week 5) were
re-randomized (1:1) to Stage 2 to receive pimavanserin 34 mg/day or
placebo. The primary endpoint of the study was the change in
HAMD-17 total score for Stage 1 and Stage 2. Treatment differences
from Stage 1 and Stage 2 were combined as weighted averages.
About Major Depressive Disorder
According to the National Institute of Mental Health, MDD
affects approximately 16 million adults in the U.S.1, with
approximately 2.5 million adults treated with adjunctive
therapy.2,3 MDD is a condition characterized by depressive symptoms
such as a depressed mood or a loss of interest or pleasure in daily
activities for more than two weeks, as well as impaired social,
occupational, or other important functioning. The majority of
people who suffer from MDD do not respond adequately to initial
antidepressant therapy.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 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 or major depressive
disorder.
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, major depressive
disorder, the negative symptoms of schizophrenia, 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 as adjunctive treatment for
major depressive disorder or other 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.
References
1National Institute of Mental Health. (2017). Major Depression.
Retrieved from
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
2IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017. 3PLOS One,
Characterization of Treatment Resistant Depression Episodes in a
Cohort of Patients from a US Commercial Claims Database, Oct 2013,
Vol 8, Issue 10. 4Rush AJ, et al. (2007) Am J. Psychiatry 163:11,
pp. 1905-1917 (STAR*D Study).
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version on businesswire.com: https://www.businesswire.com/news/home/20190924006035/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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