FanaptTreatment for Schizophrenia
Update: Fanapt Now FDA Approved - May 6, 2009
Vanda 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.
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, firstname.lastname@example.org
Web site: http://www.vandapharma.com/
Ticker Symbol: (NASDAQ-NMS:VNDA)
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Posted: November 2007
- FDA Approves Fanapt to Treat Schizophrenia - May 7, 2009
- FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date - November 20, 2008
- 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