Data from Integrated Analysis of Two Phase III Studies Show Robust
and Consistent Efficacy of NUPLAZID Across a Wide Array of Study Measures
Data from Two Open-Label Studies Demonstrate Attractive Safety and
Tolerability Profile and Potential for Long-Term Effectiveness of
NUPLAZID in Parkinson’s Disease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Jun. 16, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on innovative treatments that address unmet medical needs in
neurological and related central nervous system disorders, today
announced the presentation of integrated efficacy and tolerability data
from its Phase III program with NUPLAZID™ (pimavanserin) at the 19th
International Congress of Parkinson’s Disease and Movement Disorders
held in San Diego.
“Data from the integrated analysis of Phase III studies continue to
support the potential for NUPLAZID to safely and effectively treat
Parkinson’s disease psychosis, a condition for which there is no
approved therapy in the United States,” said Roger Mills, M.D.,
Executive Vice President, Development and Chief Medical Officer.
“Furthermore, data from our open-label safety extension studies indicate
that long-term administration of NUPLAZID is generally safe and well
tolerated in patients with Parkinson’s disease psychosis and that
duration of antipsychotic effect may be maintained for longer than the
six weeks investigated in our Phase III placebo-controlled efficacy
studies.”
Poster Presentations
Efficacy and Tolerability of NUPLAZID™ (pimavanserin) in PD
Psychosis: Analysis of an Integrated Phase 3 Placebo-Controlled Dataset
(Abstract #156)
An integrated analysis was performed on efficacy and tolerability data
from two six-week Phase III placebo-controlled clinical trials with
NUPLAZID (40 mg) in Parkinson’s disease psychosis (PDP). In this large
pooled sample of 268 patients from North America, NUPLAZID showed highly
significant improvement in psychosis compared to placebo on the 9-item
SAPS-PD scale (p<0.001). NUPLAZID demonstrated significant improvement
on each of the separate hallucinations and delusions domains and also on
secondary psychoses measures, including the Clinical Global
Impression-Improvement (CGI-I) and the Clinical Global
Impression-Severity (CGI-S) scales. In addition, NUPLAZID demonstrated
significant improvement on nighttime sleep, daytime wakefulness and
caregiver burden, representing additional potential clinically impactful
benefits. Results were consistent across all subgroups of interest,
showing greater improvement with NUPLAZID over placebo regardless of
age, sex, race group or MMSE screening score.
Pooled analysis of data from all Phase III placebo-controlled clinical
trials with NUPLAZID showed that NUPLAZID was well tolerated and had no
impairment on motor function. The adverse event profile of NUPLAZID was
similar to placebo.
Long-Term Effectiveness of NUPLAZID™ (pimavanserin) in PD Psychosis:
Data from 2 Open-Label Studies (Abstract #149)
Data from two open-label safety extension studies were presented,
including final data from a completed Phase II open-label study (-010
Study) of 39 PDP patients and interim data from an ongoing Phase III
open-label study (-015 Study) of 459 PDP patients. The interim analysis
of the ongoing -015 Study reflects data entered into the database as of
December 13, 2013. PDP patients in the -015 Study rolled in after
completing 6 weeks of blinded treatment in a Phase III
placebo-controlled efficacy, tolerability and safety trial. PDP patients
in the -010 Study rolled in following completion of the 4-week treatment
period in a Phase II placebo-controlled efficacy, tolerability and
safety trial. In both open-label studies, patients remained on treatment
for a median duration of over 15 months.
Data from the two open-label studies suggest that long-term
administration of NUPLAZID is generally safe and well tolerated in
patients with PDP. Although there are no formal efficacy endpoints in
the open-label studies, persistent antipsychotic benefit has been
observed in one or both studies across measures including SAPS-PD, other
SAPS-based outcomes, CGI-I and CGI-S. In the -015 Study, patients who
rolled in from a placebo arm showed a highly significant improvement in
SAPS-PD and CGI-S scores at Week 4 compared to their score at the end of
the 6-week randomized study. This improvement was observed for the
combined U.S. and rest-of-world patients. Persistent benefit on
caregiver burden with NUPLAZID has also been observed.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selective
serotonin inverse agonist preferentially targeting 5-HT2A receptors
that play an important role in psychosis. ACADIA has reported positive
Phase III trial results with NUPLAZID, which has the potential to be the
first drug approved in the United States for psychosis associated with
Parkinson’s disease. NUPLAZID is administered orally once-a-day. ACADIA
discovered NUPLAZID and holds worldwide rights to this new chemical
entity. The trade name NUPLAZID has been provisionally accepted by the
FDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, about one million people
in the United States and from four to six million people worldwide
suffer from Parkinson’s disease. Parkinson’s disease psychosis (PDP) is
a debilitating disorder that occurs in an estimated 40 percent of
Parkinson’s patients. Currently, there is no FDA-approved therapy to
treat PDP in the United States. PDP, which commonly consists of visual
hallucinations and delusions, substantially contributes to the burden of
Parkinson’s disease and deeply affects the quality of life of patients.
PDP also is associated with increased caregiver stress and burden,
nursing home placement, and increased morbidity and mortality. There is
a large unmet medical need for new therapies that will effectively treat
PDP without compromising motor control in patients with Parkinson’s
disease.
About ACADIA
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in neurological and related central nervous system disorders. ACADIA has
a pipeline of product candidates led by NUPLAZID™ (pimavanserin), for
which we have reported positive Phase III trial results in Parkinson’s
disease psychosis and which has the potential to be the first drug
approved in the United States for this disorder. Pimavanserin is also in
Phase II development for Alzheimer’s disease psychosis and has
successfully completed a Phase II trial in schizophrenia. ACADIA also
has clinical-stage programs for chronic pain and glaucoma in
collaboration with Allergan, Inc. All product candidates are small
molecules that emanate from internal discoveries. 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, either alone or with a partner,
including clinical trials, the benefits to be derived from ACADIA’s
product candidates, in each case including NUPLAZID (pimavanserin), the
potential for NUPLAZID to be the first drug approved in the United
States for Parkinson’s disease psychosis (PDP), the potential for
NUPLAZID to safely and effectively treat PDP, and the potential for
NUPLAZID to be effective for long-term treatment of PDP, including
beyond the 6-week treatment period of prior placebo-controlled clinical
trials. 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 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, 2014 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150616005709/en/
Source: ACADIA Pharmaceuticals Inc.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Steve
Davis, Interim Chief Executive Officer
Lisa Barthelemy,
Director of Investor Relations
(858) 558-2871
or
Media
Contact:
Chandler Chicco Companies
David Polk
(310)
309-1029 or (805) 428-5775