A federal panel on Thursday voted narrowly to recommend allowing Eli Lilly to market its blockbuster antidepressant Cymbalta for some chronic pain conditions like lower back ailments that affect millions of Americans.
The scientific advisory panel to the Food and Drug Administration voted 8-6 in favor of expanding approved uses of Cymbalta. If approved by the agency, the drug would compete with Tylenol, aspirin and other anti-inflammatory drugs, and opioids like codeine and morphine.
F.D.A. officials at the meeting assured the panel they would draft warnings against the overuse of Cymbalta for pain, if they did finally approve a label change. Advisory committee votes are often, but not always, followed by the agency.
“I think it will be a very useful drug for a significant number of patients,” Dr. Jeffrey R. Kirsch, the chairman of the advisory panel, said after the vote.
But while the committee, in a series of votes, approved the drug’s effectiveness for lower back pain, it voted against the drug’s use for osteoarthritis. The F.D.A. staff earlier in the week opposed Lilly’s broader proposal that would have allowed Cymbalta to be used for chronic pain on a host of issues.
Dr. Robert Baker, Lilly’s global development leader for psychiatry and pain disorders, said the company would continue seeking F.D.A. approval to market Cymbalta to treat all chronic pain.
In an interview, he said Lilly learned only this week that the agency had limited votes to just two conditions. “While we’d have been happy to move right to chronic pain, we are also understanding and interested in helping them capture this for doctors as they work for patients for individual subsets of pain such as osteoarthritis or lower back pain,” Dr. Baker said.
Approval for lower back pain alone could add as much as $500 million in annual sales of Cymbalta, on top of its $3 billion current sales, an investor note from Barclays Capital said Thursday.
“If you think of how many people have lower back pain, it’s an extraordinarily large opportunity,” C. Anthony Butler, a Barclays analyst, said. The Barclays note predicted Lilly, which is based in Indianapolis, would invest heavily in promotion because it was relying on Cymbalta for sales growth from next year, when its patent expires on its best-selling drug, Zyprexa, to 2013, when its patent expires on Cymbalta.
But Lilly also was criticized Thursday by the F.D.A. panel members for its advertising campaign for Cymbalta. The ads say “depression is painful.” Dr. Kirsch, who is chairman of the department of anesthesiology at the Oregon Health Sciences University, said he was perturbed at what he termed an attempt to “premarket” the drug for a pain use that had not yet been approved.
The F.D.A. approved Cymbalta for major depression and diabetic nerve pain in 2004, generalized anxiety disorder in 2007, and fibromyalgia in 2008.
The drug was used by 2.8 million patients with 14.6 million prescriptions last year, according to an F.D.A. staff report, about 400,000 of them off-label for musculoskeletal pain, headaches or nerve pain. Doctors may prescribe any approved drug for any use they see fit.
Dr. Sidney M. Wolfe, a consumer representative on the panel and director of the health research group at the nonprofit group Public Citizen, said the F.D.A. should “move slowly, if at all,” to expand approved uses of the drug. Lilly stock fell 1.4 percent, to $34.28 Thursday amid a comparable sell-off in broader markets.
Separately on Thursday, Judge Dennis M. Cavanaugh of Federal District Court in Newark ordered that no generic version of the Lilly attention-deficit drug Strattera be brought to the market for at least two weeks. Last week, the judge overturned Lilly’s patent on Strattera, which had $609 million sales last year.
Also on Thursday, Standard & Poor’s Rating Service downgraded Lilly’s corporate credit rating from AA to AA-, writing, “The rating action considers the disappointments and delays for both new and existing products experienced by this top-tier drug company, which we believe weaken its ability to offset the lost revenues for products facing generic competition over the next three years.”