DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

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

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus at screening
• Painful distal symmetric polyneuropathy
• At screening, a pain scale of ≥ 40 mm

Exclusion Criteria:

• HbA1c (National Glycohemoglobin Standardization Program) > 10.0%