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Lyrica Approval to Treat Fibromyalgia Pain Questioned By Many

Jan 14, 2008 | Parker Waichman LLP
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Lyrica, a drug made by Pfizer  for diabetic nerve pain, was approved by the Food & Drug Administration (FDA) to treat fibromyalgia pain last June.  Since then, Pfizer has engaged in a very aggressive campaign to market Lyrica as a fibromyalgia treatment.  Unfortunately, the medical community cannot agree on whether or not fibromyalgia is a real disorder.  That has led many to question whether or not Lyrica, which carries some significant side effects, should be used to treat a disease which may or may not exist.

Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis.  While patients who complain of the disorder and their doctors insist that it is real, some in the medical community assert that fibromyalgia is not a real disease.  Rather, they say that fibromyalgia is simply a physical response to stress, depression, and economic and social anxiety.  No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.  What’s more, those who dispute that such a disorder as fibromyalgia exists complain that the diagnosis of fibromyalgia itself worsens the condition by encouraging people to think of themselves as sick.   

Lyrica is the first prescription medication approved to treat fibromyalgia.   Because fibromyalgia patients typically do not respond to conventional painkillers like aspirin, Lyrica affects the brain and the perception of pain.  Pfizer’s Lyrica, known generically as pregabalin, binds to receptors in the brain and spinal cord and seems to reduce activity in the central nervous system.

No one knows exactly how Lyrica works.  But some say that Lyrica does not work well enough to have warranted its FDA approval.  According to The New York Times, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.

In 2004, Lyrica was reviewed by the FDA as a remedy for diabetic nerve pain.  The reviewers recommended against approving the drug, citing its side effects.  Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. According to the New York Times, in 12-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time.  

But the FDA ignored the advice of Lyrica reviewers, and approved it anyway.  Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June.  It was a good move for Pfizer.  According to the New York Times, worldwide sales of Lyrica reached $1.8 billion in 2007, up 50 percent from 2006. Analysts predict sales will rise an additional 30 percent this year, helped by consumer advertising.  During the first nine months of 2007, Pfizer spent $46 million on Lyrica ads.

Real or not, there is obviously a huge market for fibromyalgia treatments.  Now Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs.  Eli Lilly has asked the FDA’s approval to market the antidepressant Cymbalta to treat fibromyalgia.  Forest Laboratories is also seeking the same approval for milnacipran, an antidepressant sold in many countries, though not the United States.  Approval of both for treating fibromyalgia pain is expected later this year.

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