XTL advances pain drug to Phase IIb

The Phase IIb study is a randomized, double-blind, placebo-controlled study comparing 200mg 3x/day and 400mg 3x/day of bicifadine versus placebo, with a 1:1:1 randomization between the three arms, in patients with diabetic neuropathic pain. The trial is designed to enroll approximately 330 patients. Approximately 45 clinical centers in the US, Europe and India will participate in the study.

The primary endpoint of the study is to compare the efficacy of each of the two active doses of bicifadine (200mg and 400mg) versus placebo in reduction of pain associated with diabetic neuropathy, at baseline (at the time of randomization) versus week 14 (week 12 of the steady-state phase). Pain will be measured based on a 24-hour pain rating using the 11-point pain intensity numeric rating scale (formerly referred to as the LIKERT scale).

Bicifadine is being developed for the treatment of diabetic neuropathic pain which represents a significant unmet medical need in the rapidly growing multi-billion dollar neuropathic pain market, according to XTL. Bicifadine is a member of the SNRI drug class, a proven class in the treatment of diabetic neuropathic pain. XTL in-licensed the world-wide rights to bicifadine from Dov Pharmaceutical in January 2007.