It could be another Prozac moment.
Eli Lilly and Co. is pitching its next star antidepressant drug, Cymbalta, for approval to treat the poorly understood pain of fibromyalgia.
Regulators OK'd a drug specifically for fibromyalgia for the first time in June. The approval of Pfizer Inc.'s Lyrica sparked hope in fibromyalgia patients and advocates that more doctors will come to understand and diagnose the tricky condition, now that they have a medicine to treat it.
That's what happened 20 years ago when Lilly introduced Prozac to treat depression. Until then, many doctors hesitated to diagnose patients as clinically depressed, since the condition was poorly understood and could not be verified by a standard test. In addition, the only available treatments had significant side effects.
"If you can start finding medications that help a condition, it simply expands the medical knowledge," said Dr. Marc Duerden, a physical medicine physician at Rehabilitation Associates of Indiana. "It makes patients feel better, and I think it makes primary doctors feel better in treating these patients."
That's not an entirely good thing, however, in the minds of some doctors. Not all of them agree that fibromyalgia is a disease. Those who doubt it is a disease say it's not helpful to call it one-as both Lilly's scientists and advertisements for Lyrica do.
Fibromyalgia afflicts 10 million Americans, according to estimates by the National Fibromyalgia Association in Anaheim, Calif. About 90 percent of those are women. Doctors say it's common for those with fibromyalgia to suffer from depression, chronic fatigue or sleeping disorders.
So, if approved for fibromyalgia, Cymbalta will likely attract controversy. Lilly asked the U.S. Food and Drug Administration in the third quarter of 2007 to approve Cymbalta for fibromyalgia. Pharmaceutical analysts expect an FDA decision in the second or third quarter.
That's not so different from Prozac, which was strongly opposed by Scientologists and has been blamed by some patients' families for causing their loved ones to commit suicide.
The good news for Lilly is that Cymbalta also resembles Prozac in its blockbuster status. Cymbalta racked up $2 billion in sales last year and will soon be Lilly's topselling drug.
Its 2008 U.S. sales will pass up those of Lilly's current best-seller, Zyprexa, Lilly officials have said. And some analysts think Cymbalta will become Lilly's No. 1 drug worldwide by year's end.
The approval for fibromyalgia would make up a small part of those sales, but analysts still treat it as significant.
"Cymbalta's strong U.S. performance should be bolstered by the recently filed [fibromyalgia] indication," wrote Cowen & Co. analyst Steve Scala in a Dec. 7 note to investors.
Scala expects that total to grow another 17 percent this year and hit $3.2 billion by 2012. Another pharmaceutical analyst, Jami Rubin of Morgan Stanley, projects Cymbalta to hit $4.6 billion by 2011.
Scala expects Lilly to get the green light to launch Cymbalta in Canada and France this year. Also, he said Lilly might seek regulators' approval to market Cymbalta as a treatment for chronic lower back pain and pain associated with arthritis.
Cymbalta is already approved to treat diabetic nerve pain.
Some doctors, such as Duerden, already prescribe Cymbalta to some of their patients that suffer with fibromyalgia. He often prescribes Cymbalta along with Lyrica and an anti-anxiety pill. U.S. regulations allow doctors to prescribe drugs even for uses unapproved by the FDA.
Lilly doesn't promote Cymbalta to treat fibromyalgia, according to a spokeswoman. But it has published some of its findings from clinical trials in which Cymbalta was given to fibromyalgia patients.
In one study, published in 2005 in the medical journal Pain, doctors asked patients to rate their pain on a scale of 1 to 10 before taking Cymbalta. Then, after taking the drug for 12 weeks, they rated their pain again. The study found that 55 percent of patients, all of whom were women, had at least a 30-percent decrease in pain. Among patients taking only sugar pills during the trial, 33 percent saw significant pain reductions.
"It's a real disease," said Dr. Madelaine Wohlreich, a psychiatrist who is leading the team of Lilly researchers studying Cymbalta for fibromyalgia. She added, "There's a lot about the disease of fibromyalgia that we do not understand."
Although Cymbalta's exact mechanism of action is unknown, Wohlreich thinks the drug affects fibromyalgia by helping the brain "quiet down" pain messages coming from a patient's body.
For example, when a woman without fibromyalgia bumps her elbow, her nervous system sends pain messages to her brain. After a few minutes, the pain ebbs. For a woman with fibromyalgia, the pain from an elbow bump would linger and be felt more intensely. Fibromyalgia patients can even feel pain with no apparent cause. Scientists believe, Wohlreich said, that with fibromyalgia, the brain's ability to block out pain messages appears not to work correctly.
Scientists think Cymbalta works by increasing the amount of two brain chemicals in the spaces between the brain's nerve endings, known as synapses. By keeping the chemicals serotonin and norepinephrine in the synapses longer, Cymbalta seems to help the brain block pain messages from the body.
Dr. Frederick Wolfe agrees that people diagnosed with fibromyalgia feel real pain. He even says they may have malfunctioning nervous systems. But Wolfe, a rheumatologist, doesn't agree with Duerden and Wohlreich that fibromyalgia should be called a disease. He likens fibromyalgia to a very high fever-it's a symptom of a problem, not a disease in itself.
Wolfe acknowledges his objections are "arcane." But his doubt has been influential because Wolfe was the lead writer on a 1990 medical study that created criteria for identifying patients with fibromyalgia. Those criteria are still the standard today.
He said calling fibromyalgia a disease, for most patients, is more hindrance than help in their recovery. He noted, however, that when it comes to having insurers pay for drugs, "it's easier to get payment for drugs for a disease than for a non-disease."
But Lynne Matallana, the founder and president of the National Fibromyalgia Association, rejects that doubt-from her own experience. She said she came down with fibromyalgia in 1993 and was bedridden for 2-1/2 years. Through yoga, water therapy and drugs to treat pain and sleep disorders, Matallana recovered.
She founded the association in 1997 to raise awareness about fibromyalgia. Her organization gets some funding from Lilly, as well as from Pfizer and other drug firms.
"The approval of Lyrica has been an incredibly important milestone in the treatment of fibromyalgia," Matallana said. She added, "I also think it's important to have different approaches with this. Just like when Prozac came out, there weren't the many, many antidepressants that we have now. Different companies will approach this in different ways, and will help educate in different ways."