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| |  APA: Depressed Patients Responding Well to Once-Weekly, Enteric-Coated Fluoxetine INDIANAPOLIS, IN -- May 18, 2000 -- Research data concerning long-term treatment for depression with a novel, enteric-coated formulation of fluoxetine hydrochloride given once weekly was presented at the 153rd Annual Meeting of the American Psychiatric Association in Chicago, IL. "The potential value of the enteric-coated formulation of fluoxetine is the choice and potential convenience that it provides to patients and physicians for the long-term treatment of depression," said Rajinder Judge, director and global physician for fluoxetine with Lilly Research Laboratories. "If approved by the FDA, this new formulation can provide an important choice, such as once-weekly dosing, for patients who want an alternative for longer term therapy." Researchers examined relapse rates of 501 depressed patients who responded well to open-label acute therapy (13 weeks) with fluoxetine 20 mg and who were randomized to either a 90 mg enteric-coated formulation of fluoxetine taken once weekly (n=190), immediate release fluoxetine at 20 mg daily (n=189) or placebo (n=122) during a 25-week, double-blind continuation treatment phase. Patients involved in the study met the DSM-IV dignostic criteria for major depression. Time to relapse was measured over the 25-week continuation period using the Kaplan-Meier method, and tested using log-rank analyses of the relapse rates. Additional efficacy measures included comparisons of baseline-to-endpoint change (LOCF) on the modified HAMD-17 and CGI-Severity scales. Safety measures included comparison of treatment-emergent adverse events, both spontaneous and solicited, vital signs, and laboratory measures. Key study findings include:
* Relapse rates for depressed patients treated with either the enteric-coated or immediate release formulation of fluoxetine were significantly lower than those treated with placebo (p=.007, p < .001). In March, Eli Lilly and Company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the enteric-coated formulation of fluoxetine hydrochloride. If approved by the FDA, fluoxetine will be the first antidepressant available which offers the option of weekly dosing during long-term treatment of depression. In a sub-analysis of 139 depressed patients with high levels of baseline anxiety (HAM-D Anxiety/Somatization factor score >7), it was found that: * Time-to-relapse rates for depressed patients with high levels of anxiety treated with either weekly or daily fluoxetine dosages were significantly lower than those of placebo-treated patients (p= .0061; p= .0042). "We now know that depressed patients with high levels of anxiety may require longer periods of treatment prior to achieving recovery than patients with low anxiety," said Dr. Judge. "The similar effect of the two formulations of fluoxetine in this subset of patients is encouraging." The most commonly observed adverse events associated with the use of fluoxetine vs. placebo in U.S.-controlled clinical trials for depression, obsessive-compulsive disorder, and bulimia combined were nausea (23 vs. 10 percent), headache (21 vs. 20 percent), insomnia (20 vs. 11 percent), anxiety (13 vs. 8 percent), nervousness (13 vs. 9 percent) and somnolence (13 vs. 6 percent). Fluoxetine is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at least five weeks after discontinuation with fluoxetine. Fluoxetine should be discontinued immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified. Safety and effectiveness in pediatric patients have not been established. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.
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