Management of Painful Symptoms with Duloxetine: A Review of the Efficacy in Pre-Clinical and Clinical Studies

This is a review of the effect of duloxetine on pain in pre-clinical studies as well as in clinical studies in patients with diabetic peripheral neuropathic pain (DPNP) and fibromyalgia (FM), and painful symptoms associated with major depressive disorder (MDD) and generalized anxiety disorder (GAD). Data sources include the pre-clinical studies of duloxetine in rodent pain models, and randomized, double-blind, placebo-controlled trials of the efficacy of duloxetine (20-120 mg/day) in the management of chronic pain in DPNP and FM, and in MDD and GAD trials that included pain measures. In pre-clinical studies, duloxetine reduced pain in animal models of central and neuropathic chronic pain states. In the clinical trials, duloxetine (60-120 mg/day) significantly reduced the severity of pain in patients with DPNP and FM. In pooled analyses of the MDD and GAD studies, there was a significant main effect of treatment with duloxetine on painful symptoms. The results from these studies demonstrate that duloxetine reduces pain in pre-clinical animal studies, clinical studies of patients with FM and DPNP, and in painful symptoms associated with MDD and GAD.