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Teva Pharmaceutical Industries Ltd and Xenon Announce FDA Orphan Drug Designation for Pain Drug XEN402


Tuesday, 23 Apr 2013 08:00am EDT 

Teva Pharmaceutical Industries Ltd and Xenon Pharmaceuticals Inc. (Xenon) announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia (EM). EM is a rare autosomal dominant condition characterized by debilitating spontaneous or easily evoked attacks of symmetrical burning pain in the feet and hands, typically associated with elevated skin temperature and erythema (redness of the skin). Symptoms are generally induced by exercise, prolonged standing, exposure to heat, and/or changes in humidity. The pain can be so severe that it can lead to suicide, and adequate treatment remains very challenging. Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to drugs intended to treat rare disease or condition affecting fewer than 200,000 people in the U.S. This designation confers special incentives to the drug developer, including tax credits towards the cost of clinical trials, prescription drug user fee waivers and may entitle a period of seven years U.S. market exclusivity upon FDA approval.XEN402 is a chemical entity that has been exclusively licensed worldwide to theComapny. XEN402 inhibits the SCN9A sodium channel. Data from a published phase II study, suggest that XEN402 may relieve the pain associated with erythromelalgia (Pain 2012 Jan; 153(1):80-5).