ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on innovative treatments that address unmet medical
needs in central nervous system (CNS) disorders, today announced
the initiation of CLARITY, a Phase II study to evaluate
pimavanserin for adjunctive treatment in patients with major
depressive disorder (MDD) who have an inadequate response to
first-line therapies for clinical depression. Pimavanserin is a
selective serotonin inverse agonist (SSIA) preferentially targeting
5-HT2A receptors that may play a role in depression.
“Major depressive disorder affects millions of people in the
United States every year and many do not respond adequately to
currently available treatments,” 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. “With its highly
selective mechanism of action, pimavanserin may provide a new
approach to the adjunctive treatment of patients with major
depressive disorder and may represent an opportunity to improve
clinical outcomes in these patients.”
“We are committed to the development of pimavanserin in
additional CNS disorders that are underserved by currently
available therapies and represent a significant unmet medical need.
Inadequate response to current antidepressants is one such
condition,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s
Executive Vice President, Head of Research and Development. “We are
gratified to be able to leverage the vast knowledge and expertise
of our colleagues at MGH and conduct this study in collaboration
with the MGH Clinical Trials Network & Institute.”
About CLARITY
CLARITY is a Phase II, 10-week, randomized, double-blind,
placebo-controlled, multi-center study designed to examine the
efficacy and safety of adjunctive use of pimavanserin in patients
with major depressive disorder who have an inadequate response to
standard antidepressant therapy with either a selective serotonin
reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake
inhibitor (SNRI). Approximately 188 patients will be randomized to
receive either 34 mg of pimavanserin or placebo, orally, once
daily, in addition to their ongoing antidepressant for 10 weeks.
The primary endpoint of the study is the change from baseline on
the Hamilton Depression Rating Scale (HAM-D) total score.
About Major Depressive Disorder (MDD)
According to the National Institute of Mental Health, MDD
affects approximately 16 million adults in the United States and is
the leading cause of disability for ages 15-44. 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 to initial antidepressant therapy.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA)
preferentially targeting 5-HT2A receptors. These receptors are
thought to play an important role in depression. Pimavanserin is
being evaluated in an extensive clinical development program by
ACADIA across multiple indications. Pimavanserin (34 mg) 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 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 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.
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
progress and timing of ACADIA’s drug discovery and development
programs, the expected design and scope of ACADIA’s clinical
trials, the benefits to be derived from NUPLAZID (pimavanserin) and
ACADIA’s product candidates, including whether pimavanserin can
effectively be used to adjunctively treat MDD, provide a new
approach to the adjunctive treatment of patients with MDD or
represent an opportunity to improve clinical outcomes for patients
with MDD, and ACADIA’s future development efforts in CNS disorders
that are underserved by currently available therapies and represent
a significant unmet medical need. 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 in collaborations with others, 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, 2015 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
DEMENTIA-RELATED PSYCHOSISElderly 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 psychosis.
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.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in
patients with mild to moderate renal impairment. Use of NUPLAZID is
not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in
patients with hepatic impairment. NUPLAZID has not been evaluated
in this patient population.
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
pediatric patients.
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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version on businesswire.com: http://www.businesswire.com/news/home/20161201005387/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy(858)
558-2871ir@acadia-pharm.comorMedia Contact:Taft CommunicationsTed
Deutsch(609) 578-8765ted@taftcommunications.com
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