Cymbalta chronic pain sNDA to be resubmitted

US drug major Eli Lilly has withdrawn its supplemental New Drug Application from the Food and Drug Administration for Cymbalta (duloxetine HCl) for the management of chronic pain. Lilly plans to resubmit the NDA in first-half 2009, adding data from a recently-completed positive study in chronic osteoarthritis knee pain.

"This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application," said John Hayes, Lilly Research Laboratories vice president.

The decision does not affect duloxetine's FDA-approved indications for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia. The agent generated worldwide sales of $1.89 billion last year.