Phase III success for Cymbalta (Eli Lilly) for Peripheral Neuropathy

Daily Cymbalta( duloxetine) therapy from Eli Lilly, was effective and well-tolerated for the treatment of painful Chemotherapy-induced Peripheral Neuropathy (CIPN), according to a randomized, double-blind, placebo-controlled Phase III trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Patients were randomized to receive duloxetine followed by placebo (n=115) or placebo followed by duloxetine (n=116); initial crossover periods for each group were 6 weeks of drug/placebo followed by 1 week of washout. Of the initially-enrolled 231 participants, 81% completed the interventions and data was analyzed for 87 initial duloxetine-arm patients and 93 patients in the initial placebo arm. Pain reduction was more pronounced with duloxetine than placebo, with Brief Pain Inventory Short Form score reductions of 59% vs. 38% (for any decrease), and 21% vs. 9% for decreases of 50% or more (P=0.015). There was no difference in efficacy related to chemotherapy type.Quality of life scores (FACT/GOG-NTX and EORTC QLQ-C30) improved significantly with duloxetine (P=0.030 and 0.032, respectively).

Adverse events were rare and not significantly different between duloxetine and placebo; 7% of patients experienced duloxetine-related fatigue. Duloxetine was well tolerated.

see- -"Effect of Duloxetine on Pain, Function, and Quality of Life Among Patients With Chemotherapy-Induced Painful Peripheral Neuropathy: A Randomized Clinical Trial."-Ellen M. Lavoie Smith, PhD, Herbert Pang, PhD, Constance Cirrincione, MS,et al., for the Alliance for Clinical Trials in Oncology -JAMA. 2013;309(13):1359-1367. doi:10.1001/jama.2013.2813