870-P: Long-Term Efficacy and Safety of Crisugabalin Besilate in Chinese patients with Diabetic Peripheral Neuropathic Pain

Introduction & Objective: Chronic diabetic peripheral neuropathic pain (DPNP) exerts serious adverse effects on patients' emotions and quality of life. Crisugabalin has shown favorable efficacy and safety in a phase II/III study in Chinese patients with DPNP. In this open-label extension study, we further evaluated the long-term safety and efficacy of Crisugabalin Besilate.

Methods: A total of 301 patients with DPNP from the previous phase II/III trial were enrolled in this 52-week open-label study. Patients received Crisugabalin Besilate capsule 40mg twice daily. Pain intensity was measured with Short-Form McGill Pain Questionnaire (SF-MPQ), including Pain Rating Index (PRI), Visual Analogue Scale (VAS), and Present Pain Intensity (PPI).

Results: All the efficacy indicators of SF-MPQ showed continuous decrease throughout the trial, and the scores at week 52 were significantly different compared with baseline. The mean changes in PRI and VAS from baseline at week 52 were -2.5±3.97 and -23.4±19.38, respectively, and that the proportion of subjects with PPI ≤ 1 increased by 19% from baseline. 86.4% subjects experienced a total of 1095 Treatment Emergent Adverse Events (TEAEs) during the study, including 203 drug-related TEAEs with the incidence of 38.9%. The most common drug-related TEAEs were dizziness (27.2%) and somnolence (8.3%), and the majority were mild to moderate. The incidence of TEAEs leading to dose reduction was 14.3%.

Conclusions: Long-term treatment with Crisugabalin Besilate is effective and safe for pain relief in Chinese patients with DPNP.