SAN DIEGO--(BUSINESS WIRE)--Dec. 1, 2016--
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.”
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
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.
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
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
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
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.