Full article reprinted from "The Pink Sheet" DAILY December 14, 2009
Lilly's effort to add a chronic pain claim to Cymbalta appeared to be on a smooth track after FDA announced that the application was slated for an advisory committee, but the company is now expecting the meeting will be cancelled. Read on...
Full article reprinted from "The Pink Sheet" DAILY December 14, 2009
Cymbalta (duloxetine) had been scheduled to be reviewed by FDA's Anesthetic and Life Support Drugs Advisory Committee on Jan. 28, according to a notice in the Dec. 8 Federal Register.
The reasons for the expected cancellation are unclear, but one likely motivator would be the need to review a risk management plan. Sometimes a cancelled advisory committee has been seen as a good sign - there are no longer any outstanding issues with an application - but more recently, cancellations have signaled a more protracted review for a product.
Chronic pain would be the fifth indication for the selective serotonin and norepinephrine reuptake inhibitor, which is already approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia.
The new claim would open a vast market for a product that carries a black box warning on the "increased risk of suicidal thinking and behavior in "children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders."
Those adverse events haven't been observed in patients using Cymbalta for its current pain-related indications, and younger patients are not primary users of chronic pain medication. But the black box may have prompted regulators to ask for a stronger risk management scheme than a pain product otherwise would have.
Of course, FDA is well aware of the shortcomings of other classes of pain products, and is struggling to develop a Risk Evaluation and Mitigation Strategy for opioids. If Cymbalta appears a viable additional option with a good safety profile, it could be attractive to FDA.
Lilly presented a slide during its analyst day Dec. 10 showing that adverse events in the trials of osteoarthritis and chronic lower back pain were "consistent" with the trails of Cymbalta's current indications, and CFO Derica Rice said the chronic pain claim could provide "significant growth" that would usher in a "new phase of Cymbalta's life cycle."
Knee Pain Data Has Been Pain In The Neck For Lilly
Even if Lilly is able to address any potential safety issues, however, demonstrating efficacy in chronic pain won't be a cake walk. The application was originally submitted in the second quarter of 2008, but the firm withdrew the sNDA in November 2008, after FDA raised concerns about the statistical methods used in the trail for osteoporosis of the knee.
The firm resubmitted the application with a more recent trial that used FDA's preferred method for accounting for patients that did not complete the protocol. That study complements two Phase III trials in chronic lower back pain that Lilly conducted, as well as the data from the diabetic peripheral neuropathic pain and fibromyalgia indications.
Lilly is not disclosing the user fee date for the chronic pain application, but it first announced the resubmission in June, meaning the PDUFA goal would be April at the latest.
-M. Nielsen Hobbs
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