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| |  Extended-Release Trazodone Approved in US for Major Depressive Disorder PRINCETON, NJ -- February 3, 2010 -- The US Food and Drug Administration (FDA) has approved a novel, extended-release, once-daily formulation of trazodone hydrochloride (Oleptro) for the treatment of major depressive disorder (MDD) in adults. MDD affects more than 14 million adults in the United States and is the leading cause of disability globally. “There’s a large body of evidence demonstrating the efficacy of trazodone in the treatment of MDD,” said Stephen Stahl, MD, University of California, San Diego School of Medicine, San Diego, California. This novel formulation of trazodone “effectively treats depression and provides a tolerable adverse event profile,” he added. The efficacy of extended-release trazodone was demonstrated in an 8-week, randomised, double-blind, placebo-controlled, multicentre study in patients with unipolar major depressive disorder. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the treated group versus the placebo group. The results of this study, which are published in the May 2009 issue of Psychiatry, include the following: · Statistical significance was achieved for the primary endpoint (P = .012) In this trial, the most common adverse events associated with extended-release trazodone were somnolence/sedation, dizziness, constipation, and blurred vision. Four percent of patients in the trazodone group discontinued treatment due to somnolence or sedation. “Our research in the clinical study leading up to FDA approval showed that [extended-release trazodone] was well tolerated and demonstrated a significantly greater improvement in the HAMD-17 primary efficacy endpoint over placebo,” said Dr. David Sheehan, MD, Depression and Anxiety Disorders Research Institute, University of South Florida College of Medicine, Tampa, Florida. “When given at the recommended daily dose range, [extended-release trazodone] was an appropriate monotherapy for patients with MDD.” Labopharm will conduct a post-approval paediatric study. The FDA also has asked Labopharm to provide data from a long-term maintenance study and an additional in-vitro alcohol dissolution study.
SOURCE: Labopharm Inc.
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