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FDA Designates Orphan Drug for Rare Pain Condition

Neuron illustration (NIH)

(National Institute on Aging, NIH)

The U.S. Food and Drug Administration designated as an orphan drug the compound XEN402 to treat erythromelalgia, a rare disease that causes a burning pain in the feet and hands. XEN402 is being developed Xenon Pharmaceuticals in Burnaby, British Columbia, Canada.

Erythromelalgia is a disorder that affects the skin of the feet or hands or both, usually on both sides of the body, and causes visible redness, intense heat, and burning pain. The pain and burning sensations can be extremely severe, and people with the disease often make big changes to their lifestyles to avoid the condition. Symptoms of erythromelalgia generally occur after exercise, prolonged standing, exposure to heat, and/or changes in humidity.

The Erythromelalgia Association estimates the rate of people diagnosed with erythromelalgia at 1.3 per 100,000, with women afflicted more often (2.0 per 100,000) than men (0.6 per 100,000). The median age of people with the condition is 61.

XEN402 is a non-opioid compound to address a number of conditions involving pain, licensed to Teva Pharmaceutical Industries in Jerusalem, Israel for worldwide distribution. The compound inhibits the sodium channel found in nerve cells. The SCN9A gene provides instructions to the sodium channels that work through nociceptors, the part of nerve cells in the peripheral nervous system, which connect the brain and spinal cord to cells, and are primarily involved in transmitting pain signals.

Xenon Pharmaceuticals adapted XEN402 for oral and topical applications, which has been tested in proof of concept studies and clinical trials for pain from molar dental extractions and neuralgia, as well as erythromelalgia. An early-stage clinical trial indicates XEN402 can be effecive in treating erythromelalgia.

Orphan Drug Designation is granted by FDA for new drugs that treat rare conditions affecting fewer than 200,000 people in the U.S. The designation provides incentives to the drug developer, including tax credits toward the cost of clinical trials and prescription drug user fee waivers, with up to seven years U.S. market exclusivity.

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Hat tip: MedCity News

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