SAN DIEGO—(BUSINESS WIRE)—Sep. 3, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced it has submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) seeking approval for NUPLAZID™
(pimavanserin) for the treatment of psychosis associated with
Parkinson’s disease.
NUPLAZID is an SSIA (selective serotonin inverse agonist) preferentially
targeting 5-HT2A receptors. Through this novel mechanism,
NUPLAZID has demonstrated significant efficacy in Parkinson’s disease
psychosis (PDP) and has the potential to avoid many of the debilitating
side effects of existing antipsychotics, none of which are approved for
use in PDP patients. The FDA granted NUPLAZID Breakthrough Therapy
designation for PDP in 2014.
“NUPLAZID holds promise for patients with Parkinson’s disease psychosis
who currently have no FDA-approved treatment options,” said Steve Davis,
ACADIA’s Chief Executive Officer. “Psychosis is the leading cause for
Parkinson’s patients moving from their homes to nursing homes or other
institutions and leads to an increased risk of mortality, a diminished
quality of life and significant caregiver burden. If approved, NUPLAZID
would represent a new and distinctly different pharmacological approach
to treating psychosis and would be the first drug approved in the United
States for psychosis associated with Parkinson’s disease.”
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. An estimated 40 percent of these
patients have Parkinson’s disease psychosis, which is characterized by
hallucinations and delusions. Currently, there is no FDA-approved
therapy to treat Parkinson’s disease psychosis.
ACADIA’s NDA submission is based on data from a comprehensive
development program assessing the safety and efficacy of NUPLAZID for
Parkinson’s disease psychosis. The NDA includes data from the pivotal
Phase III -020 Study, in which NUPLAZID met all primary and secondary
endpoints with statistical significance, along with supportive data from
other studies with NUPLAZID. The -020 Study demonstrated that NUPLAZID
significantly reduced psychosis compared to placebo in patients with
Parkinson’s disease psychosis with no worsening of motor function. These
results were further supported by significant improvements in all
secondary efficacy measures and by significant benefits in exploratory
efficacy measures of nighttime sleep, daytime wakefulness and caregiver
burden. Consistent with previous studies, NUPLAZID was safe and well
tolerated in the -020 Study. Detailed results of the -020 Study have
been published in The Lancet.
ACADIA has requested a Priority Review of its NDA. If granted, Priority
Review status would accelerate the review timeline from ten months to
six months following the conclusion of the 60 calendar day filing review
period that begins on the FDA’s receipt of the NDA. The FDA informs the
applicant of a Standard or Priority Review designation following the
conclusion of this 60 calendar day period.
Separately, ACADIA issued a news release today announcing that its Board
of Directors has appointed Steve Davis as Chief Executive Officer.
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 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 has a pipeline of product
candidates led by NUPLAZID™ (pimavanserin), for which we have submitted
a New Drug Application in Parkinson’s disease psychosis to the FDA and
which has the potential to be the first drug approved in the United
States for this condition. 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 timing of the potential
approval of an NDA for NUPLAZID (pimavanserin); the potential for
NUPLAZID to be the first drug approved in the United States for
Parkinson’s disease psychosis; whether, if approved, NUPLAZID would
represent a new and distinctly different pharmacological approach to
treating psychosis; the potential for NUPLAZID to avoid many of the
debilitating side effects of existing antipsychotics; and the progress,
timing and results of ACADIA’s drug discovery and development programs,
either alone or with a partner, including the progress and expected
timing of 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 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, 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/20150903005508/en/
Source: ACADIA Pharmaceuticals Inc.
Investors:
ACADIA Pharmaceuticals Inc.
Steve Davis,
Chief Executive Officer
Lisa Barthelemy, Director of
Investor Relations
858-558-2871
or
Media:
Russo
Partners
David Schull
212-845-4271 or
858-717-2310
[email protected]