More than two years after Eli Lilly (NYSE: LLY) first applied to have Cymbalta approved to treat chronic pain, the Food and Drug Administration has finally given its stamp of approval.
After withdrawing its 2008 application, Eli Lilly resubmitted in June 2009. But it took more than a year for the FDA to hold an advisory panel for the expanded indication and a few more months to approve the drug.
Better late than never, I guess.
Of course, "too little, too late" also applies here. Cymbalta, which is currently approved for depression, anxiety, diabetes-related pain, and fibromyalgia, already derives a portion of its sales from patients seeking pain relief. The approval will allow Eli Lilly to market the drug as a treatment for chronic pain, which will boost sales some, but much of the opportunity has already been captured through off-label use.
Unlike GlaxoSmithKline (NYSE: GSK), which sold its depression treatment Wellbutrin under the separate name Zyban to treat help people stop smoking, Eli Lilly has stuck with branding Cymbalta for both indications. While depression has some negative connotations, it's likely that many people with chronic pain are at least a little depressed. The duel branding could give Eli Lilly an advantage over other pain drugs like Pfizer's (NYSE: PFE) Celebrex, Johnson & Johnson's (NYSE: JNJ) Tylenol 3 and Purdue Pharma's Oxycontin.
Whatever market opportunity the expanded label provides, Eli Lilly doesn't have much time to take advantage of it. The patent on Cymbalta expires in 2013. Like I said, "too little, too late."
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