SAN DIEGO—(BUSINESS WIRE)—Aug. 6, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
that address unmet medical needs in neurological and related central
nervous system disorders, today announced the publication of new data
from its ongoing open-label safety extension study, the -015 Study, with
NUPLAZID™ in patients with Parkinson’s disease psychosis (PDP) in the
July 31 online issue of the Journal of the American Medical Directors
Association (www.jamda.com).
This is the first published report evaluating the long-term impact of
antipsychotics on mortality and serious adverse events in patients with
PDP.
Currently marketed antipsychotics are not approved for PDP and have a
black box warning for use in elderly patients with dementia due to
increased mortality and morbidity. NUPLAZID was granted Breakthrough
Therapy designation from the FDA in 2014 and has the potential to be the
first drug approved for the treatment of PDP in the United States. In
the -015 study, all patients received NUPLAZID (40 mg). Of 423 patients
assessed, 357 received NUPLAZID only, while 66 patients received a
currently marketed antipsychotic prescribed by their physician at some
point during the study in addition to NUPLAZID. The two groups were well
matched at baseline with regard to age (mean of 71-72 years) and other
demographic and baseline variables. In a post-hoc analysis, there was a
significant increase in the mortality rate of patients who received
concurrent treatment with a currently marketed antipsychotic (18.8
deaths per 100 person-years since the first concurrent antipsychotic
dose) compared to those who received NUPLAZID only (4.5 deaths per 100
person-years).
There also was a significant increase in treatment emergent serious
adverse events in patients who received concurrent treatment with a
currently marketed antipsychotic (52.5 first-occurrence events per 100
person-years since the first concurrent antipsychotic dose) compared to
those who received NUPLAZID only (17.8 first-occurrence events per 100
person-years).
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 Pharmaceuticals
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
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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 potential for pimavanserin to
be the first drug approved in the United States for PDP, if approved at
all; the progress, timing and results of ACADIA’s drug discovery and
development programs, either alone or with a partner; and the benefits
to be derived from ACADIA’s product candidates, including pimavanserin.
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.
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Interim Chief
Executive Officer
or
Lisa Barthelemy, Director of
Investor Relations
(858) 558-2871