Results also indicated that PRX-00023 was well-tolerated, there was a low rate of discontinuation due to adverse events and side effects seen were similar to placebo, including impact on sexual function and sleep. In March 2007, EPIX announced the initiation of a randomized, double-blind, placebo-controlled Phase 2b trial in 330 patients with major depressive disorder (MDD). PRX-00023 is targeting a significant unmet medical need and commercial opportunity for a selective, once-daily, 5-HT1A agonist used in the treatment of depression that avoids the sexual dysfunction, withdrawal symptoms and sleep disturbances typically associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs), lacks the addictive and sedative effects of the benzodiazepines, and does not have the slow onset, short half-life, and side effects of a chemical class of 5-HT1A agonists called azapirones. The company has five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer’s disease, cardiovascular disease and obesity. These drug candidates include PRX-08066 in Phase 2 clinical development for pulmonary hypertension associated with chronic obstructive pulmonary disease, PRX-03140 which is in a Phase 2a clinical trial in Alzheimer’s disease, PRX-00023 which is in Phase 2b clinical development to treat major depression, and PRX-07034, which recently completed a Phase 1b trial and is in clinical development for the treatment of obesity and cognitive impairment. These statements relate to, among other things, our expectations regarding the progress, timing and results of our clinical development program for PRX-00023 and other drug candidates. read more

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