WASHINGTON, Sept. 15, 2015 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that
the U.S. Food and Drug Administration (FDA) has accepted for review
Vanda's filing of a supplemental New Drug Application (sNDA) for
Fanapt® seeking approval as a maintenance treatment of
schizophrenia in adults.
Vanda is seeking approval based on the results of the REPRIEVE
clinical study, which evaluated the long-term maintenance of
efficacy and safety of Fanapt®.
The FDA has set a user fee goal date under the Prescription Drug
User Fee Act of May 27, 2016, which
is the target date for the FDA to complete its review of the
sNDA.
About Vanda Pharmaceuticals Inc.
Vanda
Pharmaceuticals Inc. is a biopharmaceutical company focused on
the development and commercialization of products for the treatment
of central nervous system disorders. For more on Vanda, please
visit www.vandapharma.com.
About Fanapt®
Fanapt® is
an atypical antipsychotic agent indicated for the treatment of
schizophrenia in adults. In choosing among treatments, prescribers
should consider the ability of Fanapt® to prolong the QT
interval and the use of other drugs first. Prescribers should also
consider the need to titrate Fanapt® slowly to avoid orthostatic
hypotension, which may lead to delayed effectiveness compared to
some other drugs that do not require similar titration.
IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in
elderly patients with dementia-related psychosis; QT prolongation;
neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia
and diabetes mellitus; weight gain; seizures; orthostatic
hypotension and syncope; leukopenia, neutropenia and
agranulocytosis; hyperprolactinemia; body temperature regulation;
dysphagia; suicide; priapism; potential for cognitive and motor
impairment.
COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT®
(>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal
congestion, orthostatic hypotension, somnolence, tachycardia, and
weight increased.
For full U.S. Prescribing Information, including Boxed Warnings
and Important Safety Information, visit our Web site at
www.fanapt.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING
STATEMENTS
Various statements in this release, including,
without limitation, statements regarding the target completion date
of the FDA's review of the sNDA, are "forward-looking statements"
under the securities laws. Forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties, including, without
limitation, risks that the FDA will not complete its review of the
sNDA by the user fee goal date or that the FDA may not ultimately
approve the sNDA. Important factors that could cause actual results
to differ materially from those reflected in Vanda's
forward-looking statements are set forth in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Vanda's annual report on
Form 10-K for the fiscal year ended December 31, 2014 and
quarterly report on Form 10-Q for the quarter ended
June 30, 2015, which are on file with
the SEC and available on the SEC's website at www.sec.gov. In
addition to the risks described above and in Vanda's annual report
on Form 10-K and quarterly reports on Form 10-Q, other
unknown or unpredictable factors also could affect Vanda's results.
There can be no assurance that the actual results or developments
anticipated by Vanda will be realized or, even if substantially
realized, that they will have the expected consequences to, or
effects on, Vanda. Therefore, no assurance can be given that the
outcomes stated in such forward-looking statements and estimates
will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is provided
only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
Corporate Contact:
Jim
Kelly
Senior Vice President and Chief Financial
Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.