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ARTICLE | Clinical News

Cymbalta duloxetine: Phase III data

April 8, 2013 7:00 AM UTC

A double-blind, crossover, U.S. Phase III trial in 231 patients with chemotherapy-induced peripheral neuropathy showed that Cymbalta for 5 weeks met the primary endpoint of reducing average pain as measured by BPI-SF scores from baseline vs. placebo (1.06 vs. 0.34 points, p=0.003). Additionally, 59% of patients receiving Cymbalta reported a reduction in pain of any amount vs. 38% for placebo. Patients received placebo for 5 weeks or once-daily 30 mg Cymbalta for 1 week followed by twice-daily 30 mg Cymbalta for 4 weeks. The initial 5-week treatment period was followed by a 2-week washout period after which patients crossed over to the other treatment group for weeks 8-12. Data were published in the Journal of the American Medical Association. The trial was sponsored by the National Cancer Institute (NCI). Eli Lilly did not respond in time for publication regarding next steps. ...