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Report From Results Of A Successful Phase II Study For DARA's KRN5500 At ADEPT

Is it the Medication or is it the Placebo Response That's Making You Feel Better? Scientists Are Attempting to Understand the Phenomenon

RALEIGH, N.C., March 29, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) reported that researchers studying a new medication for neuropathic pain have reported intriguing findings about placebo response from a Phase 2a proof-of-concept study. They presented their findings at the 2011 International Conference on Accelerating the Development of Enhanced Pain Treatments.

Their findings could lead to more accurate results in future similar pain medication trials.  In clinical pain trials, patients are given either the drug being evaluated or an identically appearing placebo, then report on whether the drug has helped their pain by rating it on a scale from 0 to 10. Since pain is such a subjective symptom, patient self-reporting is the only way researchers can ascertain the degree of pain management.

Subjective outcomes can be difficult to assess

In their presentation, researchers Christine K. Moore, PhD, Susan E. Spruill, PStat, and Linda G. Jett, MSN, reported the results from a trial evaluating the safety and tolerance of a new medication, KRN5500, being developed by DARA BioSciences. In earlier studies conducted by the National Cancer Institute, KRN5500 showed promise for relieving neuropathic pain which often afflicts cancer patients. It is common that patients appear to respond to the placebo in pain trials where subjective outcome data are collected. Researchers are often faced with a dilemma: Is the drug a failure or is the placebo response too great to see the drug response?

According to Dr. Moore, "One of the most significant problems in clinical trials of pain medication is that there is often not enough difference between the drug and the placebo because the placebo response is so high. Patients want to feel better. The placebo effect can be as high as 40% to 50%, requiring an even higher drug effect to show a difference."

We want to feel better so we deceive ourselves

Ms. Spruill, the study's statistician, explained, "The problem is that there is always a placebo response. That's because as humans we can manifest a psychological and/or physical response even when there is no real treatment. That effect can't be held forever, but we can certainly be tricked for a short period of time. And pain is one of those areas in which we're good at tricking ourselves."

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