From the Canadian drug company Xenon www.xenon-pharma.com - "Our pain product, XEN402, is partnered with Teva and is being developed initially for the treatment of the orphan neuropathic pain disorder erythromelalgia. XEN402 has concluded phase 2a proof-of-concept studies and has been granted orphan designation by the FDA".
Wow.
Jerusalem, Israel, and Burnaby, British Columbia, (April 23, 2013) – Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Xenon Pharmaceuticals Inc. (Xenon) announced today 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 novel 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.
“We are very pleased to receive orphan drug designation for XEN402. Through development of this drug, we hope to address the significant unmet medical need for patients who suffer from chronic pain related to erythromelalgia,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “XEN402, which inhibits the SCN9A sodium channel, is being developed as a non-opioid approach to pain management.”
“The granting of this orphan-drug designation is another important milestone for our XEN402 development” said Simon Pimstone, President and CEO of Xenon. “Xenon was founded with a commitment to identifying novel targets and from these, novel drugs for difficult to treat rare diseases. 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.”
awesome!!!!!!!!!!!!!!!
Anybody know anything about this “new drug” that was posted in 2013?
Funapide, formerly known as XEN402, remains under development by Xenon Pharmaceuticals and Teva Pharmaceutical Industries as a novel analgesic. It is being evaluated in both oral and topical formulations. A phase IIb clinical trial for postherpetic neuralgia was completed in the United States in early 2017. Funapide acts as a small-molecule Nav1.7 and Nav1.8 voltage-gated sodium channel blocker.
Further information on this fledgling drug class can be found here:
Funapide at Wikipedia:
Thanks Carter. I take it we can’t get our hands on this stuff as of now until it passes phase II. I can always expect you to respond with such great detailed responses and I appreciate that !
That’s right. It is currently unavailable. If Teva ever applied for and received FDA approval for the chemical compound, it would be available off label even if approved first for postherpetic neuralgia. There is obviously enough interest in the chemical Teva and Xenon have created a name for it (Funapide).