ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on innovative treatments that address unmet medical
needs in central nervous system disorders, today announced the
initiation of ENHANCE-1, a Phase III study to evaluate pimavanserin
for adjunctive treatment of schizophrenia in patients with an
inadequate response to current antipsychotic therapy. Current
antipsychotics approved for schizophrenia primarily target the
dopaminergic pathway. As a selective serotonin inverse agonist
(SSIA), pimavanserin is a new class of antipsychotic medication
with a distinct mechanism of action targeting serotonergic 5-HT2A
receptors while avoiding activity at dopamine and other receptors
commonly targeted by other antipsychotics.
“About 30 percent of patients with schizophrenia do not achieve
an adequate response to a single antipsychotic medication, and as a
result more than one in four schizophrenia patients are treated
with two or more antipsychotics,” said Serge Stankovic, M.D.,
M.S.P.H., ACADIA’s Executive Vice President, Head of Research and
Development. “We believe pimavanserin, through its highly selective
mechanism of action, could provide an important new option for
adjunctive treatment of schizophrenia and improve clinical outcomes
by both augmenting the efficacy of currently used antipsychotics
and lessening the undesirable side effects associated with
polypharmacy.”
About ENHANCE-1
ENHANCE-1 is a Phase III, six-week, randomized, double-blind,
placebo-controlled, multi-center, outpatient study designed to
examine the efficacy and safety of adjunctive use of pimavanserin
in patients with schizophrenia who have not achieved an adequate
response to their current antipsychotic treatment. Approximately
380 patients will be randomized to receive pimavanserin, or
placebo, orally, once daily, in addition to their ongoing
antipsychotic in a flexible dosing regimen. The starting daily dose
of 20 mg of pimavanserin at baseline may be adjusted to 34 mg or 10
mg during the first three weeks of treatment. The primary endpoint
of the study is the change from baseline to week six on the
Positive and Negative Syndrome Scale (PANSS) total score. Following
participation in ENHANCE-1, patients will be eligible to enroll in
a 52-week open-label extension study.
About Schizophrenia
According to the National Mental Health Institute, approximately
one percent of the U.S. population develops schizophrenia during
their lifetime. Schizophrenia is a chronic, debilitating mental
illness characterized by disturbances in thinking, emotional
reaction, and behavior. These disturbances may include positive
symptoms, such as hallucinations and delusions, and a range of
negative symptoms, including loss of interest, emotional withdrawal
and cognitive disturbances. Current drugs used to treat
schizophrenia have substantial limitations, including severe side
effects and a lack of efficacy on the full range of symptoms of the
disease.
According to the American Psychiatric Association, about 30
percent of patients with schizophrenia have inadequate response to
antipsychotic medications, meaning that they exhibit improvement,
but continue to have residual hallucinations or delusions. As a
result, about 25 to 50 percent of schizophrenia patients are
treated with two or more antipsychotics. This polypharmacy has led
to increased dose-related side effects and complicated dosing
regimens that can further contribute to poor treatment compliance
and subsequent relapse in these patients.
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 schizophrenia. 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 schizophrenia.
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, and the benefits to be derived from NUPLAZID (pimavanserin)
and ACADIA’s product candidates, including whether pimavanserin
could provide an important new option for adjunctive treatment of
schizophrenia or improve clinical outcomes by augmenting the
efficacy of currently used antipsychotics and/or lessening the
undesirable side effects associated with polypharmacy. 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 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.
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/20161103005542/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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