SAN DIEGO--(BUSINESS WIRE)--Nov. 3, 2016--
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.”
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.
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.
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.
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
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.