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XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
Date:9/10/2007

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ABOUT DIABETIC NEUROPATHIC PAIN

Diabetic neuropathic pain is a chronic pain condition resulting from damage to nerves in patients with diabetes. Diabetic neuropathic pain, which manifests itself primarily in the feet, can often be debilitating thus preventing patients from carrying out their normal day-to-day activities. In the United States, it is estimated that 4.5 million patients with diabetes suffer from diabetic neuropathic pain. Diabetic neuropathic pain is the largest segment in the rapidly growing market for neuropathic pain drugs. This market was estimated at $1.8 billion in 2005, and is expected to grow to $5.5 billion by 2015. Only two oral drugs have been approved to date by the FDA for the treatment of diabetic neuropathic pain (Eli Lilly's Cymbalta(R), an SNRI, and Pfizer's Lyrica(R)); however, the response rates to these drugs are limited. Consequently, millions of patients remain without adequate treatment options and seek new drugs that could provide better relief for their chronic pain.

ABOUT THE SNRI DRUG CLASS

Serotonin and Norepinephrine Reuptake Inhibitors (SNRI's) are drugs that increase the levels of serotonin and norepinephrine in the brain, thus blocking pain signals. SNRI is a proven drug class in diabetic neuropathic pain as well as Major Depressive Disorder. One SNRI (Eli Lilly's Cymbalta(R)) is already approved for the treatment of diabetic neuropathic pain, while a second SNRI (Wyeth's Effexor(R)) has demonstrated efficacy in treatment of diabetic neuropathic pain in large, randomized and placebo-controlled studies. Both Cymbalta(R) and Effexor(R) are also approved for depression. A third SNRI (Cypress' Milnacipran(R)) recently demonstrated efficacy in a Phase III trial in a related neuropathic pain indication (fibromyalgia), providing f
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SOURCE XTL Biopharmaceuticals Ltd
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