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FDA funds Rochester researchers to give chronic and acute pain clinical trials a makeover
Date:11/14/2011

For chronic pain sufferers, a day can feel like a year and a year can feel like an eternity. With very few truly new therapies approved by the U.S. Food and Drug Administration for this condition since 2005, the outlook is far from bright.

Fortunately, the FDA has taken note. With up to $4.5 million in funding from the agency over the next five years, researchers at the University of Rochester Medical Center will study different approaches to improve the methods used to evaluate and approve new, safe, and effective treatments for the more than 76 million Americans with acute and chronic pain.

"Pain can cause considerable suffering and it represents an enormous financial burden to society," said Robert H. Dworkin, Ph.D., professor in the Department of Anesthesiology and the Center for Human Experimental Therapeutics at the Medical Center, who will spearhead the research. "Despite substantial attention in the pharmaceutical industry to developing novel pain therapies, the fact that so few improved treatments have become available is really surprising and is why the FDA is funding this initiative."

According to Dworkin, one possible reason pain clinical trials are often unsuccessful is that patients in the placebo group, who get a dummy pill instead of the real treatment, frequently show greater-than-expected improvements. Consequently, it becomes difficult for researchers to show meaningful differences between the pain-lessening effects of the real drug and the dummy drug.

The FDA agrees that the problem may lie in the way new pain therapies are identified and studied.

"We've seen over the years that analgesic [pain] clinical trials frequently fail, and often with drugs that we know work. When opioids that have been known to be effective for hundreds of years are put in clinical trials, we can't get a positive result," said Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Drug Product
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Contact: Emily Boynton
emily_boynton@urmc.rochester.edu
585-273-1757
University of Rochester Medical Center
Source:Eurekalert

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