The committee voted 8-6 in favor of expanding the use of its depression-turned-pain-drug Cymbalta into patients with chronic pain. That's not exactly a resounding endorsement.
And it only gets more ambiguous from there. Eli Lilly used studies in patients that had back pain and those with osteoarthritis to support the chronic pain indication. The committee voted 8-5 that the data supported Cymbalta's use in back pain but with a 4-9 vote, found that the data didn't support its use in osteoarthritis.
This is normally where I'd point out that the FDA usually -- but not always -- follows the advice of the committee, but with mixed advice, it seems that the FDA is pretty much on its own here. It's not clear exactly when the agency might make its decision since the PDUFA date came and went many months ago.
What is clear is that Eli Lilly could use the additional sales. Pending appeal, the company is at the losing end of patent fight over attention-deficit-disorder drug Strattera. If it can't convince a court otherwise, generic competition from Teva Pharmaceutical
If the FDA does give Eli Lilly the green light to market Cymbalta for the expanded indication, they seem to have a tag line all set up. The advertisements for Cymbalta say that "depression is painful". Flip it around -- "pain is depressing" -- and you've got one drug that can treat both. That's something Pfizer's
Jim Royal doesn't see any pain in today's 11 o'clock recommendation.
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