ViibrydTreatment for Depression
Update: Viibryd (vilazodone) Now FDA Approved - January 21, 2011
NDA Submitted for Vilazodone
Clinical Data Submits NDA for Depression Compound
NEWTON, Mass. – March 23, 2010 – Clinical Data, Inc. today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The Company expects that the NDA submission, if accepted, will be subject to a standard review.
"This is a major milestone in the development of vilazodone and, if approved, its dual mechanism of action and safety profile will offer a new alternative for patients suffering from depression," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "We are very encouraged by the results seen to date in vilazodone's clinical development and look forward to working with the Agency during the review process."
The NDA submission is based on a comprehensive development program for vilazodone, which includes two randomized, double-blind, placebo-controlled Phase III clinical trials. In both of these eight-week trials, the efficacy of vilazodone was substantiated as shown by its superiority to placebo, with statistically significant results for the primary and multiple secondary endpoints. Results from efficacy measures in an uncontrolled long-term safety study were consistent with these findings. In Phase III studies, most adverse events were mild to moderate in intensity and consistent with vilazodone's expected pharmacologic effect; the most common adverse reactions included diarrhea, nausea and insomnia. Typically, these adverse reactions occurred early in treatment and did not result in discontinuation of treatment with vilazodone. Overall, vilazodone has been shown to have a good safety profile and to be well tolerated in a database of nearly 2,900 patients treated for up to 52 weeks.
"This is an extraordinary accomplishment for Clinical Data to complete our NDA submission for vilazodone and to meet our goal by delivering it to the FDA this quarter, as promised," said Drew Fromkin, Clinical Data's President and Chief Executive Officer.
Depression is a highly prevalent mood disorder with significant morbidity and mortality. The National Institute of Mental Health estimates that major depressive disorder affects approximately 18.1 million adults in the U.S. and that the medical and social costs of depression in the U. S. in the year 2000 was $83 billion, including both $26 billion in costs of treatment and $57 billion in losses such as absenteeism, reduced productivity at work, and the value of lifetime earnings lost due to suicide-related deaths. Further, approximately 60% of MDD patients have a comorbid psychiatric condition, including 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 treatment.2 More than 212 million prescriptions were written for antidepressants in 2009, with commonly prescribed agentss accounting for approximately $12 billion.3
Vilazodone is a novel, dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist in development for the treatment of major depressive disorder. Selective serotonin reuptake inhibitors, which enhance the availability of synaptic 5-HT, are approved as safe and effective treatments for depression and 5-HT1A receptor partial agonists have been shown to be effective for mood disorders including depression and anxiety. The efficacy of vilazodone in the treatment of MDD has been substantiated as shown by its superiority 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. Vilazodone is currently not approved 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 other major therapeutic areas. Clinical Data combines its drug development and biomarker expertise in an effort to develop products with enhanced efficacy and tolerability to improve patient health and reduce 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 our products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; 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. These risks and uncertainties include, but are not limited to, risks related to whether vilazodone or any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they 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; 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 republish 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, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2009, and Current Reports on Form 8-K filed from time to time by the Company.
CONTACT INFORMATION: Theresa McNeely Vice President Corporate Communications Clinical Data, Inc. 617-527-9933 x3373
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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
Paul Kidwell 617.296.3854: Office 617.680.1088: Mobile
Posted: March 2010
- Actavis Receives FDA Approval for Viibryd (vilazodone HCl) 20mg Once Daily as a Therapeutic Dose - March 16, 2015
- FDA Approves Viibryd to Treat Major Depressive Disorder - January 24, 2011
- Clinical Data, Inc. Announces Issuance of New U.S. Patent for Vilazodone - November 16, 2010
- Clinical Data, Inc. Announces FDA Acceptance of New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder - May 24, 2010