anxiety disorders, panic disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder
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Yul Brynner
Last Reset: 03:05, 14 May 06
MediciNova, Inc., has announced the results of its Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-305 in 416 patients with Generalized Anxiety Disorder (GAD). Trends for improvement in all efficacy outcome measures were observed in patients. Statistically significant improvements in item 1 of the HAM-A (anxious mood) were observed through eight weeks of treatment with MN-305, however, statistical significance on the primary outcome measure of the trial (change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score) was not achieved. MN-305 was well tolerated at all doses in the trial.
"The findings in the latest trial with MN-305 were sufficiently positive and encouraging to warrant further clinical evaluation of this novel drug," said Executive Chairman and CEO of MediciNova, Inc, Yuichi Iwaki, M.D., Ph.D. "We intend to initiate a new Phase II/III trial of MN-305 later this year focusing on improvements in the psychic symptoms of GAD and on exploring an extended dose range."
MN-305 is a highly selective serotonin 5-HT1A receptor agonist under development by MediciNova for the treatment of anxiety disorders beginning with GAD. In addition to the results from the latest clinical trial, this compound showed preliminary evidence of efficacy in animal models of anxiety and in an open-label study conducted in Japan by Mitsubishi Pharma Corporation in a group of patients with a variety of anxiety disorders. As in the latest clinical trial, MN-305 was well tolerated in previous clinical studies involving over 800 volunteers and patients with either anxiety or mood disorders.
MediciNova acquired a license to MN-305 from Mitsubishi Pharma Corporation for global markets, with the exception of Japan and other selected Asian countries.
posted Monday, 12 June 2006
tags: generalized anxiety disorder mn305 gad