A recent study investigated whether a new sustained-release (SR) pregabalin formulation is non-inferior to immediate-release (IR) pregabalin in alleviating peripheral neuropathic pain.

This phase 3 study included patients with diabetic peripheral neuropathy or postherpetic neuralgia from 41 sites in South Korea and randomized them (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150 to 600 mg/d) in a double-dummy manner for 12 weeks. It looked for the Daily Pain Rating Scale score at the end of treatment.

 319 randomized patients completed the 12-week treatment (SR pregabalin: n=154; IR pregabalin: n=165; per-protocol set: n=296). The study found the least square mean difference between both groups for the primary endpoint as 0.06, with the lower limit of the confidence interval above the pre-specified margin. It found similar Drug-related treatment-emergent adverse events (TEAEs) between both groups and a low incidence of drug-related TEAEs leading to treatment discontinuation. Furthermore, the study noted no serious drug-related TEAEs or deaths.

This study demonstrates that the new once-daily SR pregabalin formulation is non-inferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain and is well tolerated in patients with diabetic peripheral neuropathy or postherpetic neuralgia after 12 weeks of treatment.

Source: The Clinical Journal of Pain. 2022;38(5):343-350. doi: 10.1097/AJP.0000000000001028