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Phase 2b trial of TV-45070 for treatment of osteoarthritis pain halted
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Xenon Pharmaceuticals and Teva Pharmaceutical Industries have announced that a phase 2b study of TV-45070 for the treatment of pain in osteoarthritis did not demonstrate a significant difference from placebo, and research into the drug for osteoarthritis will be discontinued, according to a press release.
TV-45070 is a Nav1.7 sodium channel inhibitor designed to be applied topically around knees affected with osteoarthritis (OA).
“The rationale for development of TV-45070 in OA has unfortunately not been confirmed with these results. However, neuropathic pain represents a distinct mechanism of chronic pain to OA and, as such, the potential for positive study results in PHN [post-herpetic neuralgia] is not impacted by these data,” Richard Malamut, MD, Teva’s vice president and head of Pain Therapeutic Development, said in the press release. “Given the favorable safety and tolerability profile demonstrated, we remain hopeful that TV-45070 can offer a new and valuable option to patients with neuropathic pain.”
The randomized, double-blind, placebo-controlled phase 2b trial included 389 patients with primary osteoarthritis in one knee who met prespecified VAS pain scores. Patients were randomly assigned at a 1:1:1 ratio to a 4% or 8% TV-45070 concentration treatment group or a placebo group. Xenon developed the drug and later partnered with Teva in 2012 in an exclusive licensing agreement.
Efficacy was assessed by comparing answers to question one of the WOMAC pain scale about evening pain scores after walking on a flat surface from baseline and after treatment. Neither the group who received 4% or 8% concentrations of TV-45070 demonstrated efficacy superior to placebo, according to the release.
Reference : www.xenon-pharma.com.