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 SERENE, a Phase II study with pimavanserin for the
treatment of agitation in patients with Alzheimer’s disease (AD
Agitation). There is currently no drug approved by the FDA for the
treatment of AD Agitation. Pimavanserin is a selective serotonin
inverse agonist (SSIA) preferentially targeting 5-HT2A receptors,
with a distinct mechanism of action compared to other currently
available medicines used off-label to treat AD Agitation.
“AD Agitation is a common condition and a major cause of
distress for Alzheimer’s patients, their families and caregivers,”
said Serge Stankovic, M.D., M.S.P.H., ACADIA’s Executive Vice
President, Head of Research and Development. “It also is associated
with more rapid decline and earlier institutionalization of
patients with AD Agitation. With no FDA-approved therapy for AD
Agitation, there is a large, unmet need for a new treatment option
for patients.”
About the SERENE Study
SERENE is a Phase II, randomized, double-blind,
placebo-controlled, multi-center outpatient study designed to
examine the efficacy and safety of pimavanserin in approximately
430 patients with Alzheimer’s disease who have agitation and/or
aggression symptoms. Patients will be randomized to receive once
daily oral doses of 34 mg pimavanserin, 20 mg pimavanserin or
placebo for 12 weeks. The primary endpoint in the study is a
reduction in total score on the Cohen-Mansfield Agitation Inventory
(CMAI). Following participation in SERENE, patients will be
eligible to enroll in an open-label safety extension study.
About Alzheimer’s Disease Agitation (AD Agitation)
According to the Alzheimer’s Association, around 5.4 million
people in the United States are living with Alzheimer’s disease and
approximately half are diagnosed with the disease. Studies suggest
that 40 to 50 percent of patients diagnosed with Alzheimer’s
disease in the United States exhibit agitation. AD Agitation is
characterized by verbal aggression, physical aggression, and
excessive motor activities. These behavioral symptoms have been
associated with more rapid cognitive decline, greater caregiver
burden, and earlier institutionalization.
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 AD Agitation. 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 treatment of AD Agitation.
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 the
potential effectiveness of pimavanserin in AD Agitation patients.
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/20161031005429/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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