June 3, 2009
Lilly resubmits Cymbalta application
Eli Lilly and Co. of Indiana has resubmitted an application to the Food and Drug Administration for approval of its antidepressant Cymbalta for chronic pain.
Lilly said Wednesday the resubmission is based on a recently completed study of chronic lower back pain and pain caused by osteoarthritis, the Indianapolis Star reports.
Vice President John Hayes of Lilly Research Laboratories says the company has additional data that wasn't available when Lilly submitted its original application.
We believe including these new data in the updated ... package will provide a broader clinical basis for the FDA to review the application, Hayes said.
Lilly withdrew its original request for approval of Cymbalta for chronic pain after FDA reviewers questioned the effectiveness of the drug, pointing to issues related to the methodology and dosing in some of the trials.
Cymbalta is already approved for the treatment of depression, diabetic nerve pain and fibromyalgia.