Lilly Pursues OK For Cymbalta For Chronic Pain: Drug maker will take case to treat chronic pain to FDA panel [The Indianapolis Star]
From Indianapolis Star (IN) (August 18, 2010)
Aug. 18--As its pipeline of new drugs continues to sputter, Eli Lilly and Co. is pushing hard to squeeze more uses out of its existing products.
The latest example is Cymbalta, an antidepressant that Lilly hopes to market for chronic pain. On Thursday, the Indianapolis drug maker will make its case before a Food and Drug Administration advisory committee that the drug is a safe, effective treatment for chronic pain, an ailment that affects up to 45 million Americans.
Getting federal approval to market the drug for chronic back or knee pain could add more than $500 million in annual sales, according to Seamus Fernandez, a drug analyst at Leerink Swann & Co. in Boston. Some other analysts say Lilly increasingly needs to get more uses out of its medicine chest.
"Getting another approval for Cymbalta would be very helpful, no doubt about that," said Barbara Ryan, a drug analyst at Deutsche Bank in Greenwich, Conn. "Lilly is not getting anyone excited about its pipeline in the short term."
Cymbalta already is the nation’s fourth-most advertised prescription drug and Lilly’s second-best-selling product, with sales last year of $3.1 billion, up 14 percent from a year earlier. The drug is currently approved for four conditions: depression, anxiety, fibromyalgia and diabetic nerve pain.
But Lilly is making no bones that Cymbalta has room to grow. Lilly’s chief financial officer, Derica Rice, told analysts last year that getting approval for chronic pain would provide "significant growth" that could bring about "a new phase of Cymbalta’s life cycle."
Only one in four people receives adequate treatment for the condition, the company said. The company studied Cymbalta’s use in more than 2,400 patients for chronic pain in 12 late-stage clinical trials.
"We believe it’s important for those patients to have as many different treatment options as possible, because the responses to medicine can be highly individualized," said Dr. James M. Martinez, Lilly’s medical director for Cymbalta.
An FDA staff report released this week concluded that the drug helps people with chronic pain and isn’t linked to any new side effects. No patients died while taking the drug during clinical trials.
Still, some analysts expect the panel to look closely at the drug’s benefit-risk profile. Like all antidepressants, Cymbalta carries a black-box warning for increased risk of suicide among people younger than 25.
"It’s pretty clear that Cymbalta is an effective treatment for depression and for anxiety, but given its safety profile, should it be a widely used medication for pain?" said Robert Hazlett, a drug analyst for BMO Capital Markets in New York. "I’m sure discussion will be had about whether there is good, clear data and how to manage such a risk."
A green light from the FDA would mark the end of a long, bumpy road on the chronic pain indication for Cymbalta. In 2008, Lilly withdrew an application after the FDA questioned the methodology and dosing of some of the company’s trials. The company later submitted a new application, with more data. In January, the FDA canceled a meeting for Lilly’s request, saying it needed more time to review the new information.
And Lilly might approach the FDA again for another proposed use down the road. The company has studied Cymbalta for a raft of other possible uses, including urinary stress incontinence, irritable bowel syndrome and pain associated with multiple sclerosis and breast cancer, according to the web site ClinicalTrials.gov.
The company declined to comment about sales projections or possible future uses of Cymbalta. Nor did it say whether it expects to get FDA approval.
Cymbalta provided amazing relief for my neuropathic pain and depression though it also seemed to have bad side effects. The night terrors I experienced were unimaginable and occurred almost nightly. I had taken this medication for over a year and after choosing to discontinue it, the withdrawal symptoms that followed seemed severe. I would advise a cautious approach.