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 chronic low back pain 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
