Eli Lilly Resubmits Cymbalta Supplemental New Drug Application To FDA

Eli Lilly has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain, to the FDA.

The resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia.

Earlier, Lilly submitted the sNDA in the second quarter of 2008, but withdrew the application in November 2008 following discussions with FDA about statistical methodology and study design.

John Hayes, Vice President at Lilly Research Laboratories, said: The additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission. We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application.