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Sep 22, 2006

Epix Pharmaceuticals’ Clinical Results Find Candidate May be More Useful for Depression than Anxiety

  • Epix Pharmaceuticals reported that top-line results from its Phase III trial of PRX-00023, a long-acting 5-HT1A agonist, show that PRX-00023 did not achieve a statistically significant improvement over placebo for the primary endpoint.

    The primary efficacy endpoint was change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) compared to placebo. There was a trend in favor of patients treated with PRX-00023 in the HAM-A assessments. However, the outcome was potentially impacted by a higher than expected response in the placebo-treated patients.

    The data from this trial did show a statistically significant improvement from baseline in the Montgomery Asberg Depression Rating Scale (MADRS), compared to placebo. The MADRS, which measures symptoms of depression, was a secondary endpoint in this trial.

    “We are disappointed that treatment with PRX-00023 did not induce a statistically significant change in the HAM-A in patients with anxiety; however, we are encouraged by the MADRS data and will further analyze these results to better understand the potential benefits of PRX-00023 in patients with depression,” says Michael G. Kauffman, M.D., Ph.D., CEO.

    “Based on these top-line results, we plan to refocus our efforts away from anxiety to evaluate the benefit in depression more closely and assess opportunities for initiating a Phase III clinical trial in depression sooner than originally planned.”

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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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