Cymbalta Scores Big

The U.S. FDA has approved Cymbalta for fibromyalgia. It’s true. Eli Lilly, the world’s largest maker of psychiatric drugs, has finally won U.S. regulatory approval to sell the drug Cymbalta for fibromyalgia.

The U.S. Food and Drug Administration’s clearance allows Lilly to sell Cymbalta for symptoms of fibromyalgia, a little-understood ailment that causes debilitating pain and fatigue.

Cymbalta, which Lilly expects to be its top-selling drug in the United States this year, is also used to treat depression, anxiety and diabetic pain.

The medicine generated $2.1 billion in sales last year, and will compete with Pfizer Inc.’s pain medicine Lyrica, which was approved for fibromyalgia in June 2007.

Lyrica, also sold for nerve pain from shingles and diabetes, had sales of $1.8 billion in 2007. It is the only other medicine approved for fibromyalgia.

As many as 4 percent of Americans have the ailment, according to the American College of Rheumatology.

Cymbalta is in a family of medicines known as serotonin norepinephrine reuptake inhibitors, which act on two brain chemicals to ease depression.

The drug reduced chronic pain by half in 33 percent to 36 percent of patients who took it for six months, compared with 22 percent on a placebo, Lilly reported at a medical conference in August.

Forest Laboratories Inc. and Cypress Bioscience Inc. also have asked the FDA for permission to market their drug for fibromyalgia, milnacipran, and expect a decision by October 2008.

About 90 percent of fibromyalgia patients are female. Symptoms include headache, irritable bowel syndrome, and hand and foot numbness.

“It’s a real disease,” Dr. Madelaine Wohlreich told IBJ in February. Wohlreich is 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. With fibromyalgia, the brain’s ability to block out pain messages appears not to work correctly.

-Newswire