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 disorders, today announced it will present data from
its Phase 2 CLARITY study, which evaluated the efficacy, safety,
and tolerability of pimavanserin as an adjunctive treatment for
major depressive disorder (MDD) at the 2019 American Psychiatric
Association Annual Meeting in San Francisco, May 18 – 22, 2019.
Poster PresentationPoster:
#P8-049Date/Time: Tuesday, May 21, 2:00 p.m. – 4:00 p.m. Pacific
TimeTitle: CLARITY: A Phase 2 Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of Adjunctive
Pimavanserin in Major Depressive Disorder
The Phase 2 CLARITY study was a 10-week, randomized,
double-blind, placebo-controlled, multi-center, two-stage
sequential parallel comparison design study that evaluated the
efficacy, safety, and tolerability of pimavanserin (34 mg once
daily). Pimavanserin was administered as an adjunctive treatment in
patients with MDD who had an inadequate response to a stable dose
of standard antidepressant therapy with either a selective
serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine
reuptake inhibitor (SNRI). The study randomized 207 patients across
27 clinical research centers in the U.S. and was conducted in
collaboration with the Massachusetts General Hospital (MGH)
Clinical Trials Network and Institute.
“There is a significant need for new therapies for the majority
of patients suffering from major depressive disorder who do not
respond to initial antidepressant therapy,” said Professor Maurizio
Fava, M.D., Executive Vice Chair, Department of Psychiatry, MGH,
Director of the Division of Clinical Research of the MGH Research
Institute, and Associate Dean for Clinical & Translational
Research, Harvard Medical School. “The results observed in the
Phase 2 CLARITY study combined with a favorable tolerability
profile provides evidence that adjunctive treatment with
pimavanserin may provide meaningful benefit to those MDD patients
who have an inadequate response to either a SSRI or a SNRI
therapy.”
In the trial, pimavanserin met the overall primary endpoint of
the weighted average results of Stage 1 and Stage 2 by
significantly reducing the 17-item Hamilton Depression Rating Scale
total score compared to placebo (p=0.039). On the key secondary
endpoint, pimavanserin demonstrated statistically significant
reductions compared to placebo in the Sheehan Disability Scale
score (p=0.004). Positive results were also observed for seven
other secondary endpoints, including improvement in daytime
sleepiness as measured by the Karolinska Sleepiness Scale and
improvement in sexual function as measured by the Massachusetts
General Hospital Sexual Functioning Index.
“In this Phase 2 study of pimavanserin as an adjunctive
treatment for MDD, we found patients treated with pimavanserin
experienced significant reduction in their depression symptoms in
addition to improvement in daytime sleepiness and sexual function
when compared to placebo,” said Serge Stankovic, M.D., M.S.P.H.,
ACADIA’s President. “These results are encouraging for patients
with MDD who may experience challenges with their current treatment
options. We look forward to further evaluating pimavanserin as an
adjunctive treatment in our ongoing Phase 3 CLARITY program.”
On April 25, ACADIA announced it had initiated its Phase 3
CLARITY program for pimavanserin as an adjunctive treatment for
MDD. The CLARITY-2 study will be based in the U.S. and has already
initiated enrollment and the CLARITY-3 study will be based outside
the U.S. and will initiate enrollment in the upcoming months. Both
studies are six-week, parallel-designed, randomized, double-blind,
placebo-controlled, multi-center studies designed to evaluate the
efficacy and safety of pimavanserin as adjunctive treatment in
patients with MDD who have an inadequate response to standard
antidepressant therapy with either a SSRI or a SNRI.
About Major Depressive DisorderAccording 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 PimavanserinPimavanserin is a selective serotonin inverse
agonist and antagonist preferentially targeting 5-HT2A receptors.
These receptors are thought to play an important role in
depression, psychosis, and other neuropsychiatric disorders. ACADIA
is evaluating pimavanserin in an extensive clinical development
program across multiple indications with significant unmet need
including dementia-related psychosis, schizophrenia inadequate
response, schizophrenia-negative symptoms, and MDD. 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 the adjunctive treatment of patients
with MDD.
About ACADIA PharmaceuticalsACADIA 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 inadequate response,
schizophrenia-negative symptoms, major depressive disorder, and
Rett syndrome. This press release and further information about
ACADIA can be found at: www.acadia-pharm.com.
Forward-Looking StatementsStatements 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 MDD 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.
References1National 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/20190518005003/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Mark Johnson,
CFA(858) 261-2771ir@acadia-pharm.com
Media Contact:ACADIA Pharmaceuticals Inc.Maurissa Messier(858)
768-6068media@acadia-pharm.com
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