An Asian, phase 3, multicenter, randomized, double-blind, placebo-controlled 14-week study of DS-5565 in patients with diabetic peripheral neuropathic pain followed by a 52-week open-label extension

In this study, DS-5565 was administered at doses of 15 mg QD, 10 mg BID, or 15 mg BID for 14 weeks, including the titration period, to evaluate the efficacy and safety of DS-5565 in Asian patients with DPNP. The mean changes from baseline in ADPS at Week 14 were greater as the daily dose of DS-5565 was increased, and the differences versus placebo were statistically significant in the 15 mg BID group. DS-5565 at a dose of 15 mg BID or below is considered safe and well tolerated.