Fanapt
iloperidone
Treatment for SchizophreniaVanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
ROCKVILLE, Md., November 27, 2007 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. Acceptance of the NDA confirms that the application is sufficiently complete for FDA review.
About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder that affects approximately one percent of Americans. Patients suffering from schizophrenia exhibit a range of symptoms, which include positive symptoms such as hallucinations, delusions, negative symptoms such as emotional withdrawal and cognitive symptoms associated with significant impairment in social and occupational functioning.
Unmet Needs in Schizophrenia
Although there are many drugs approved to treat schizophrenia, including the commonly prescribed "atypical antipsychotics," a high degree of dissatisfaction remains among physicians and patients. The recent CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, conducted by the National Institute of Mental Health (NIMH) and reported in The New England Journal of Medicine, evaluated several antipsychotic medications and revealed that 74% of patients taking antipsychotics discontinued treatment within 18 months, primarily because of insufficient efficacy and tolerability issues.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. In addition to iloperidone, Vanda is developing VEC- 162, a compound for the treatment of sleep and mood disorders which is currently in Phase III development for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in Phase II development for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
Note Regarding Forward-Looking Statements
This release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding Vanda's plans for its
product candidates. Words such as, but not limited to, "look
forward to," "believe," "expect," "anticipate," "estimate,"
"intend," "plan," "targets," "likely," "will," "would," "should,"
and "could," and similar expressions or words identify
forward-looking statements. Such forward-looking statements are
based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Vanda is at an early
stage of development and may not ever have any products that
generate significant revenue. Important factors that could cause
actual results to differ materially from those reflected in Vanda's
forward-looking statements include, among others, a failure of
Vanda's product candidates to be demonstrably safe and effective, a
failure to obtain regulatory approval for the company's products or
to comply with ongoing regulatory requirements, a lack of
acceptance of Vanda's product candidates in the marketplace, a
failure of the company to become or remain profitable, Vanda's
inability to obtain the capital necessary to fund its research and
development activities, a loss of any of the company's key
scientists or management personnel, and other factors that are
described in the "Risk Factors" section (Part II, Item 1A) of
Vanda's report on Form 10-Q for the quarter ended September 30,
2007 (File No. 000-51863). No forward-looking statements can be
guaranteed and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Vanda undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
CONTACT: Steven Shallcross, Chief Financial Officer of VandaPharmaceuticals Inc., +1-240-599-4500, steven.shallcross@vandapharma.com
Web site: http://www.vandapharma.com/
Ticker Symbol: (NASDAQ-NMS:VNDA)
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Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone - July 28, 2008
Vanda Pharmaceuticals Submits Iloperidone New Drug Application - September 27, 2007
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