A recent study investigated the non-inferiority of sustained-release (SR) pregabalin formulation to immediate-release (IR) Pregabalin for peripheral neuropathic pain in Korean patients.This phase 3 study included Korean patients with diabetic peripheral neuropathy or postherpetic neuralgia who were randomized (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150 to 600 mg/d) for 12 weeks.

The daily Pain Rating Scale score was assessed at the end of treatment.The results were as follows-86.0% of the patients completed the 12-week treatment.The least-square mean difference between both groups for the primary endpoint was found to be 0.06, with the lower limit of the confidence interval exceeding the pre-specified margin.

Both groups revealed similarities regarding Drug-related treatment-emergent adverse events (TEAEs).

A low incidence of drug-related TEAEs causing treatment discontinuation was noted.

No serious drug-related TEAEs or deaths were noted.Thus the new once-daily SR pregabalin formulation can be regarded as non-inferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain. It is also well-tolerated in Korean patients with diabetic peripheral neuropathy or postherpetic neuralgia after 12 weeks of treatment.