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Clinical Trials

Date: 2015-04-02

Type of information: Recruitment of the first patient

phase: 2b

Announcement: recruitment of the first patient

Company: Teva Pharmaceutical Industries (Israel) Xenon Pharmaceuticals (Canada)

Product: TV-45070 (formerly XEN402)

Action mechanism:

sodium channel blocker. TV-45070 (formerly XEN402) is a topically applied small-molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. TV-45070 has potentially broad application in nociceptive pain, mediated by damage or injury to tissues, including the pain sensitivity caused by inflammation, and neuropathic pain mediated by damage, dysfunction or injury of nerves. The pain target Nav1.7 was identified by Xenon using its Extreme Genetics discovery platform. Xenon developed TV-45070 through early clinical development and partnered with Teva through a collaborative development and license agreement established in 2012, providing Teva with an exclusive worldwide license to develop and commercialize TV-45070. 

Disease:

postherpetic neuralgia 

Therapeutic area: CNS diseases - Neurological diseases

Country: USA

Trial details:

The Phase 2b clinical study in PHN is a randomized, double-blind, placebo controlled, multi-site study that will evaluate the safety and efficacy of topically applied TV-45070 ointment compared with placebo. (NCT02365636)

 

Latest news:

* On April 2, 2015, Teva Pharmaceutical Industries and Xenon Pharmaceuticals announced that the first patient has been enrolled into the Phase 2b study designed to evaluate the safety and efficacy of the novel topically applied TV-45070, (4% and 8% w/w ointment) in patients with postherpetic neuralgia (PHN). Teva is currently conducting a 300-patient, randomized Phase 2b clinical trial of TV-45070 in osteoarthritis of the knee, with data expected in the third quarter of 2015.

Is general: Yes