Full article reprinted from "The Pink Sheet" DAILY December 2, 2008
Read about why Lilly acknowledged the importance of using FDA's preferred statistical analysis methods when the firm withdrew its sNDA for Cymbalta (duloxetine) for chronic pain management.
Full article reprinted from "The Pink Sheet" DAILY December 2, 2008
Lilly Feels Statistical Pain, Withdraws Cymbalta sNDA
Lilly acknowledged the importance of using FDA's preferred statistical analysis methods when the firm withdrew its sNDA for Cymbalta (duloxetine) for chronic pain management.
FDA raised concerns about efficacy and dosing of Cymbalta for the new indication that revolved primarily around statistical methodology and study design, Lilly stated in the Nov. 28 release announcing the withdrawal.
The firm said that one of the three new studies submitted to support the new indication did not meet its primary endpoint when analyzed by the FDA analgesic division's preferred statistical analysis method for handling data for patients who do not complete the study: the BOCF, or Baseline Observation Carried Forward.
The trial, which was conducted in patients with osteoarthritis pain of the knee, met its primary endpoint using an analytical method known as the MMRM, or Mixed Model Repeated Measures. BOCF was used as a secondary endpoint.
FDA is wrestling with how best to handle the missing data from trials and has contracted with the National Academy of Sciences to consider the issue.
Lilly plans to submit a revised application in the first half of 2009. The resubmission will include data from a recently completed positive study in chronic osteoarthritis pain of the knee, which the firm said achieved statistical significance using both BOCF and MMRM. The revised application will also include additional dosing analyses from the studies in the original sNDA.
The original submission included two new Phase III studies in chronic lower back pain, in addition to the study in osteoarthritis pain of the knee.
Cymbalta is approved for acute and maintenance treatment of major depressive disorder and acute treatment of generalized anxiety disorder, as well as for two pain indications: the management of diabetic peripheral neuropathic pain, and fibromyalgia.
-Jamie Hammon
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