Cymbalta Trials for treatment of panic attacks and anxiety

Among 2418 duloxetine-treated patients for major depressive disorder, 1139 patients participated in eight 8- or 9-week, placebo-controlled trials at doses ranging from 40 to 120 mg/day, while the remaining 1279 patients were followed for up to 1 year in an open-label safety study using flexible doses from 80 to 120 mg/day. Two placebo-controlled studies with doses of 80 and 120 mg/day had 6-month maintenance extensions. Of these 2418 patients, 993 duloxetine-treated patients were exposed for at least 180 days and 445 duloxetine-treated patients were exposed for at least 1 year.

Among 1074 duloxetine-treated patients for diabetic peripheral neuropathy, 568 patients participated in two 12- to 13-week, placebo-controlled trials at doses ranging from 20 to 120 mg/day. An additional 449 patients were enrolled in an open-label safety study using 120 mg/day for a duration of 6 months. Another 57 patients, originally treated with placebo, were exposed to duloxetine for up to 12 months at 60 mg twice daily in an extension phase. Among these 1074 patients, 484 had 6 months of exposure to duloxetine, and 220 had 12 months of exposure.

In one trial nearly a fifth of the volunteers testing duloxetine, dropped out after a 19-year old student committed suicide at a company laboratory. The student, Traci Johnson, was one of 25 healthy patients at an Eli Lilly clinic who were being given larger than therapeutic doses of duloxetine. Four days before her death, Ms. Johnson was taken off duloxetine and given a placebo.

Four other patients who were given the drug during earlier trials also committed suicide, the company said.

Ms. Johnson's death came less than a week after a federal advisory panel concluded that the Food and Drug Administration should issue stronger warnings to doctors that this class of antidepressants may be linked to suicide and violent behavior in children and teenagers.

Duloxetine as Cymbalta now comes with a suicide risk warning for children and adolescents.



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