Pain reduction was maintained over 52 weeks with crisugabalin in people with diabetic neuropathic pain, alongside a consistent safety profile. This open-label extension of the HSK16149-201/301 trial, published in the Journal of Diabetes Research, included 301 patients (mean age 59.7 years; 58.1% male) who had previously received crisugabalin or placebo. 

All participants received crisugabalin 80 mg/day for an additional 52 weeks. The primary endpoint was safety, and the secondary endpoint assessed pain control using the Short-Form McGill Pain Questionnaire (SF-MPQ). 

Treatment-related adverse events (TRAEs) were reported in 38.9% (117/301) of patients. The most frequent TRAEs were dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%). Grade 3 or higher TRAEs occurred in 1.7%. TRAEs led to dose reduction in 13.6%, while treatment interruption and discontinuation were each reported in 1.0% of patients.

At week 52, the mean change from baseline in SF-MPQ pain rating index was −2.5 (95% CI −2.9 to −2.0; p < 0.0001), and the visual analog scale score decreased by −23.4 (95% CI −25.6 to −21.2; p < 0.0001). The proportion of patients with present pain intensity (PPI) score ≤1 increased by 19.0% from baseline (p < 0.0001). These findings indicate sustained analgesic response over long-term treatment.