8-PUB: High-Dose Crisugabalin Significantly Improving the Pain Symptoms in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)

Introduction and Objective: Dose titration challenges associated with conventional medications hinder the attainment and maintenance of optimal therapeutic doses in patients with DPNP, leading to suboptimal analgesia. This study explores the efficacy and safety of Crisugabalin (40/80/120/160 mg/d) in patients with DPNP, aiming to identify high-dose responsive subgroups and broaden the high-dose safety window through subgroup analysis. Methods: This study utilized a multicenter, single-arm clinical design. Eligible patients were aged between 18 and 75 years, had been diagnosed with DPNP, and had a NRS pain score of 4 or higher. Starting from Day 1, participants were administered Crisugabalin at an initial dose of 40 mg/d. Based on efficacy and tolerability, the dose was gradually increased to 80 mg/d within 1 week. Subjects were required to visit the hospital for follow-up at the end of each treatment week, during which pain relief was assessed. If pain relief was inadequate but the current dose was well-tolerated, dose escalation was initiated on the day of follow-up: the dose was increased from 80 mg/d to 120 mg/d, with a maximum escalation to 160 mg/d for maintenance treatment. The entire treatment course lasts for 4 weeks. Results: The study plan was designed to recruit 120 participants, and 14 of them completed the study. At week 4, the mean change from baseline in the ADPS was -3.983 ± 1.556. Notably, the dosage of 9 participants was increased to the high-dose groups (120 or 160 mg/d). Crisugabalin also showed more significant improvements in the ADSIS scores and the weekly relative changes in ADPS compared with the baseline. These participants presented a superior response rate of NRS reduction ≥30% and ≥50% from the baseline compared with Phase III clinical studies, without an increase in the incidence or severity of TEAEs. These TEAEs were generally self-limiting, resolved without intervention. Conclusion: Interim data suggest significant efficacy and a favorable safety profile of high-dose Crisugabalin in Chinese patients with DPNP. Disclosure Y. Gao: None. J. Ying: None. C. Tan: None. Y. Yang: None. C. Deng: None. Y. Li: None. R. Mao: None. S. Yan: None. W. Chen: None. X. Ran: None.