Daiichi Sanky (TYO: 4568), a pharmaceutical company based in Japan, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Tarlige (mirogabalin) for the treatment of diabetes peripheral neuropathic pain (DPNP). Mirogabalin is a gabapentinoid drug, which belongs to the same class as pregabalin, a widely used medication for various pain conditions.
The approval was supported by the outcomes of the DS5565-A-A315 study, a randomized, double-blinded, placebo-controlled Phase III clinical trial conducted in China. The study enrolled 393 subjects and evaluated the efficacy and safety of mirogabalin in treating DPNP. The findings indicated that the group administered a 15mg twice daily dose of the drug demonstrated a statistically significant improvement in pain scores at week 14 (P=0.0301) compared to the placebo group. Additionally, the drug significantly enhanced the overall perception of pain, sleep, and patient quality of life.- Flcube.com
