Eli Lilly Canada announced today that Health Canada has approved Cymbalta® (duloxetine HCl) for the management of chronic low back pain (CLBP). The recommended dose is 60 mg once daily.
The approval is based on the results of two randomized, double-blind, 12-13 week, placebo-controlled studies in 637 adult patients with a clinical diagnosis of CLBP with pain present on most days for at least 6 months and no sign of radiculopathy or spinal stenosis. The primary efficacy endpoint in both studies was a reduction in pain severity as measured by the Brief Pain Inventory (PBI) 24-hour average pain rating on the 11-point Likert scale (0 = no pain; 10 = worst possible pain). In both studies, patients taking Cymbalta 60 mg once daily experienced significantly greater pain reduction compared to placebo. In addition, some patients reported pain reduction as early as one week into the trial after starting the 60 mg dose, which continued throughout the study.
Cymbalta has been evaluated for safety in 698 patients with CLBP. The most common side effects reported in the two studies included nausea, insomnia, somnolence, constipation, dry mouth, fatigue and dizziness.
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