SAN DIEGO--(BUSINESS WIRE)--Jul. 25, 2017--
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that it has
been ranked 11th on Forbes Magazine’s 2017 list of the
World’s Most Innovative Growth Companies. ACADIA is a biopharmaceutical
company dedicated to developing and delivering innovative medicines to
address unmet medical needs in central nervous system (CNS) disorders.
“We are pleased to be recognized by Forbes as a leader in
innovation,” said Steve Davis, ACADIA’s President and Chief Executive
Officer. “Being named to this list is a testament to our team’s hard
work and commitment to developing transformational medicines that
improve the lives of patients suffering from major CNS disorders. Our
breakthrough antipsychotic NUPLAZID is the first drug approved by the
FDA for patients suffering from Parkinson’s disease psychosis. We are
currently studying the drug in five additional disease states including
unmet needs in Alzheimer’s disease, schizophrenia and depression.”
Forbes’ ranking is based on the “innovation premium” of each
company, and only includes industries that are known to invest in
innovation. To qualify for consideration in the annual list, companies
must have at least seven years of public financial data and a market
capitalization between $2 billion and $10 billion.
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 benefits to be derived from
ACADIA’s commercial products and development compounds, including
NUPLAZID. 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, and
commercialization, 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, 2016 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
Contraindication: NUPLAZID is contraindicated in patients with a history
of hypersensitivity reaction to pimavanserin or any of its components.
Reactions have included rash, urticaria, tongue swelling, circumoral
edema, and throat tightness.
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.