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Crisugabalin (40 mg/day and 80 mg/day) markedly improves average daily pain score, offering flexible dosing based on individual response and tolerability, with no new safety concerns in postherpetic neuralgia-affected patients.
In a study published in "JAMA Dermatology", Crisugabalin proved valuable for postherpetic neuralgia (PHN) pain management. The goal was to investigate Crisugabalin's efficacy and safety in PHN. The study, conducted at 48 tertiary care centers in China, consisted of two parts. Part 1 was a phase 3, placebo-controlled, multicenter, double-blind assessment with a 2-week screening, 7-day run-in, and 12-week therapy period. On the other hand, Part 2 was a 14-week open-label extension.
The trial enrolled PHN sufferers with an average daily pain score (ADPS) of at least 4 on the numeric pain rating scale (NPRS). Overall, 366 adults (193 men) were randomized to get either Crisugabalin (40 mg/day or 80 mg/day) or placebo for about 12 weeks. Alteration from baseline in ADPS at week 12 was the key endpoint ascertained. Both 40 mg/day and 80 mg/day of Crisugabalin offered superior pain relief over placebo. At week 12, the mean (standard deviation) change from baseline in the ADPS was −2.2 (0.2) for Crisugabalin 40 mg/day, and −2.6 (0.2) for Crisugabalin 80 mg/day, compared to −1.1 (0.2) for placebo.
The least squares mean differences were −1.1 for the 40 mg/day dose and −1.5 for the 80 mg/day dose, both showing remarkable improvements over placebo. Notably, the study also found that Crisugabalin was well-tolerated, with no novel safety concerns reported throughout the trial. The flexibility of dose selection—40 mg/day or 80 mg/day—allows for tailored treatment based on individual patient needs, making Crisugabalin (an oral calcium channel α2δ-1 subunit ligand) a promising addition to the available therapeutic options.
JAMA Dermatology
Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic Neuralgia A Phase 3 Randomized Clinical Trial
Daying Zhang et al.
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