Clinical Data, Inc. Announces Vilazodone Data Featured at the 2010 U.S. Psychiatric & Mental Health Congress

Update: Viibryd (vilazodone) Now FDA Approved - January 21, 2011

- Data Supports Novel Mechanism of Action and Tolerability of Vilazodone for the Treatment of Major Depressive Disorder –

NEWTON, Mass.--(BUSINESS WIRE)--Nov 22, 2010 - Clinical Data, Inc. (NASDAQ: CLDA), today announced that data from clinical trials of vilazodone, a novel investigational compound for the treatment of major depressive disorder (MDD) were presented at the annual meeting of the United States Psychiatric & Mental Health Congress. The presentations include results from two placebo-controlled Phase III clinical trials of vilazodone, as well as from a long-term safety study demonstrating vilazodone's therapeutic profile as a potential treatment for MDD. A New Drug Application for vilazodone was accepted for review by the U.S. Food and Drug Administration (FDA) on May 21, 2010 with January 22, 2011 currently assigned for decision-making by the FDA under the Prescription Drug User Fee Act (PDUFA).

“These data demonstrate the clinical profile of vilazodone, including its effects on overall sexual function, which was shown to be similar to placebo when measured by validated scales,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “Its unique mechanism of action as both a Serotonin 1A receptor Partial Agonist and Reuptake Inhibitor (SPARI), would make vilazodone, if approved, the first compound with a new mechanism to treat depression in well over a decade.”

USPC Presentation Summaries:

Minimal Impact of Vilazodone on Sexual Function During Treatment of Major Depressive Disorder

 

Anita Clayton, M.D., the David C. Wilson Professor of Psychiatry, University of Virginia School of Medicine, et al.

 

Poster #106, Session: Friday, November 19 11:30 AM – 4:30 PM
 
Vilazodone's impact on overall sexual function at 40 mg/day during acute treatment of MDD was similar to that of placebo as measured by validated scales, with supportive evidence from a long-term study.
The Safety and Tolerability Profile of Vilazodone in Patients with Major Depressive Disorder

 

Harry Croft, M.D., San Antonio Psychiatric Research Center et al.

 

Poster #107, Session: Friday, November 19 11:30 AM – 4:30 PM
 
This report summarizes the safety and tolerability profile of vilazodone 40 mg/day based on three Phase III studies conducted as part of the vilazodone's clinical development program. Based on the overall Phase III safety profile, vilazodone was generally well tolerated during both short- and long-term treatment of MDD.
The Efficacy Profile of Vilazodone, a Novel Dual-Acting Serotonergic Antidepressant in the Treatment of Major Depressive Disorder

 

Michael E. Thase, M.D., Professor of Psychiatry, University of Pennsylvania School of Medicine, et al.

 

Poster #108, Session: Friday, November 19 11:30 AM – 4:30 PM
 
This evaluation summarizes efficacy results from two randomized, double-blind, placebo-controlled, 8-week studies, including demographic and clinical subgroup assessments, and effectiveness data from a 1-year, open-label study.
About Depression

Depression is a highly prevalent mood disorder with significant morbidity and mortality. The National Institute of Mental Health estimates that MDD affects approximately 18.1 million adults in the U.S. Further, approximately 60% of MDD patients have a comorbid psychiatric condition, such as anxiety-related disorders and posttraumatic stress disorder.1 Despite advances in the understanding of pharmacotherapy and the ongoing development of new agents, overall effectiveness is unsatisfactory and approximately two-thirds of patients do not achieve remission with first-line depression therapies.2 More than 212 million prescriptions were written for antidepressants in 2009, and commonly prescribed therapies accounted for approximately $12 billion.3

About Vilazodone

Vilazodone is a novel dual-acting modulator of serotonin neurotransmission in development for the treatment of MDD with the potential for follow-on indications including Generalized Anxiety Disorder and other related mood disorders. Vilazodone has a unique dual mechanism of action and is a Serotonin 1A Receptor Partial Agonist and Reuptake Inhibitor (SPARI). Vilazodone, to which Clinical Data holds exclusive worldwide rights from Merck KGaA, Darmstadt, Germany, is currently under review by the FDA with a PDUFA data of January 22, 2011. Nearly 2,900 patients have been exposed to vilazodone in the clinical development program. The efficacy of vilazodone in the treatment of MDD was shown to be superior to placebo in two randomized, Phase III clinical trials. Results of an uncontrolled long-term safety study were consistent with the findings of the placebo-controlled studies. The most common adverse events associated with vilazodone in clinical trials were diarrhea, nausea, and insomnia. Vilazodone is currently not approved for marketing by the FDA.

About Clinical Data, Inc.

Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in major therapeutic areas including oncology and inflammatory diseases. Clinical Data plans to differentiate its therapeutics by combining its drug development and biomarker expertise to develop products with enhanced efficacy and tolerability, improving patient health and reducing costs. To learn more, please visit the Company's website at www.clda.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to obtain regulatory approval for, and successfully introduce, vilazodone and our other drug candidates; our ability to expand our long-term business opportunities; and all other statements regarding future performance. All such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements contained in this press release. These risks and uncertainties include, but are not limited to, whether vilazodone or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, vilazodone or any of our other therapeutic products will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether vilazodone or any of our other therapeutic products will be successfully marketed if approved; the strength of our intellectual property rights, including, but not limited to, our patents for the various polymorphic versions of vilazodone; competition from pharmaceutical, biotechnology and diagnostics companies; general economic conditions; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to publish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2010, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2010, and Current Reports on Form 8-K filed from time to time by the Company.

1 Rush A. John et al. Comorbid psychiatric disorders in depressed outpatients: Demographic and clinical features. J Affect Disord 2005 Jul 87 (1):43-55
2 STAR*D Study, January, 2006 American Journal of Psychiatry
3 IMS Health's National Prescription Audit and National Sales Perspective

 

Contact: Clinical Data, Inc.
Theresa McNeely, 617-467-6673
Vice President, Corporate Communications

 

 

Posted: November 2010

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