Teva Pharmaceutical and Xenon Pharmaceuticals have announced the FDA orphan drug designation for analgesic XEN402 being developed to treat pain associated with erythromelalgia (EM).
The novel chemical entity XEN402 is designed to inhibit the SCN9A sodium channel.
Teva Pharmaceutical Industries has exclusive worldwide license to XEN402 that earlier demonstrated to relieve from pain associated with EM in a phase II study.
Commenting on the designation, Teva Pharmaceutical Global R&D president and chief scientific officer Dr. Michael Hayden said development of the drug will address the significant unmet medical need for patients who suffer from chronic pain related to erythromelalgia.
"XEN402, which inhibits the SCN9A sodium channel, is being developed as a non-opioid approach to pain management," Hayden added.
Debilitating spontaneous or easily evoked attacks of symmetrical burning pain in the feet and hands, associated with elevated skin temperature and erythema are the characteristic features of autosomal dominant condition EM.
Xenon president and CEO Simon Pimstone said, "We are excited by the promise XEN402 has shown in early proof-of-concept trials and are committed to its development as a novel therapy for the treatment of pain associated with erythromelalgia."
