Drugmaker Eli Lilly withdraws drug application to treat chronic pain

Drugmaker Eli Lilly and Co said on Friday it withdrew an application to market its anti-depressant Cymbalta (duloxetine HCl) for the management of chronic pain because US health regulators raised questions about the drug's effectiveness and dosing.

Cymbalta is Eli Lilly's second best seller, after the anti-psychotic Zyprexa. In the first nine months of 2008, the company reported worldwide Cymbalta sales $1.98 billion.

Lilly said it planned to resubmit the application in the first half of 2009, adding data from "a recently completed positive study in chronic osteoarthritis pain of the knee".

The company said the decision does not affect duloxetine's FDA-approved indications for major depressive disorder, generalised anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

Lilly submitted the chronic pain application in the second quarter of 2008 based primarily on outcomes of three clinical trials: one positive study in chronic osteoarthritis pain of the knee and two studies, -- one positive and one that is supportive but didn't meet its primary endpoint -- in chronic low back pain. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.

Lilly said it made its decision to pull the supplemental New Drug Application for Cymbalta, or duloxetine HCl, after US Food and Drug Administration reviewers questioned the design of supporting Lilly studies and statistical methodology.