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NEW DRUG SHOWS PROMISE IN NEUROPATHY TRIALS

by Ed Bryant

Includes photo of Ed Bryant

One painful diabetes complication is neuropathy, nerve disease. Most frequently manifesting in the feet and legs (see "Diabetic Foot Pain," by Kenneth B. Rehm, DPM, in this issue), the condition can cause burning, itching, stabbing, indescribable agony, or even complete numbness. Neuropathy can seriously impact quality of life. It can be disabling.

Although there are a number of ways individuals cope, with varying success, these treatments and medications have been applied "trial and error," with little scientific support for such use. No medication has yet been approved by the Food and Drug Administration (FDA) for treatment of diabetic peripheral neuropathy (DPN, the most common form), but that fact is about to change.

Pregabalin, from Pfizer, has successfully completed all its clinical trials, and is currently under FDA review for this use and others (though when the FDA will act is not known). To date, it has been studied in more than 10,000 patients, and in randomized controlled trials -- far more extensively than the FDA requires. Dr. Russell Portenoy, M.D., one of the researchers who tested the drug, who I interviewed on June 8, said: "Pregabalin is the most extensively studied neuropathy medication in history. Definitive data prove that it works for DPN, and the expectation is that it will be coming on the market as the only one FDA-approved for this usage."

"No drug is a panacea," says Dr. Portenoy, Chairman, Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, "so we'll need many weapons in this fight, but Pregabalin will be an important new weapon. There's no evidence that it does anything for the neuropathy; it's not a cure for the neuropathy; it's a treatment for the pain. This is going to be a widely used, and good, drug for the pain, but in no way a panacea, no drug is."

Dr Portenoy is right; it's an exciting new development. Stay tuned; we'll let you know when Pregabalin becomes available.