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Home » EPIX'S ANXIETY DRUG DOES NOT REACH STUDY ENDPOINT
EPIX'S ANXIETY DRUG DOES NOT REACH STUDY ENDPOINT
September 22, 2006
Epix Pharmaceuticals announced that the results from its Phase III trial of PRX-00023, a long-acting 5-HT1A agonist, show that overall 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 with placebo. There was a trend in favor of patients treated with PRX-00023 in the HAM-A assessments; however, the outcome was potentially affected by a higher-than-expected response in the placebo-treated patients.
The trial was a double-blind, placebo-controlled, multicenter study with approximately 310 patients with moderate-to-severe general anxiety disorder. Patients were randomized equally into one of two arms: placebo or treatment with PRX-00023, where patients received a dose of 40 mg once daily for three days followed by 80 mg once daily for the remainder of the study. A preliminary review has indicated that PRX-00023 was well-tolerated and there was a low rate of discontinuation in this study due to adverse events. Side effects, including impact on sexual function and sleep, in patients receiving PRX-00023, were similar to placebo.
The data from this trial did show a statistically significant improvement from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) compared with placebo. The MADRS, which measures symptoms of depression, was a secondary endpoint in this trial. The company is continuing to analyze the data.
"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 II clinical trial in depression sooner than originally planned," said Michael Kauffman, CEO of Epix.
KEYWORDS Drug Pipeline Alert
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