For reduction of peripheral neuropathic pain, the novel once-daily sustained-release pregabalin formulation (in daily doses of 150–600 mg/day) was well-tolerated and showed non-inferiority to twice-daily immediate-release pregabalin.

A phase 3, randomized, double-blind, active-controlled study was carried out to compare the efficacy and safety of novel sustained-release vs. immediate-release pregabalin for management of peripheral neuropathic pain.

The study recruited people suffering from diabetic peripheral neuropathy or postherpetic neuralgia. Participants were randomly assigned to get once-daily sustained-release pregabalin or twice-daily immediate-release pregabalin (150–600 mg/day) in a double-dummy manner for twelve weeks as per a stratified permuted block randomization scheme. The daily pain rating scale score at the end of therapy, averaged from the last seven available scores was the major outcome ascertained.

Overall, 86.0% (319/371) randomized people finished the twelve-week treatment (immediate-release pregabalin: n=165; sustained-release pregabalin: n=154; per-protocol set: n=296). For the primary outcome, the least square mean difference between both the groups was 0.06 (standard error 0.19), with the lower limit of confidence interval above the pre-specified margin.

Drug-associated treatment-emergent adverse events were similar between both groups. The occurrence of drug-related treatment-emergent adverse events leading to treatment discontinuation was low (immediate-release pregabalin: 1.1%; sustained-release pregabalin: 2.7%). There were no severe drug-associated treatment-emergent adverse events or deaths.

The novel sustained-release pregabalin formulation appears to be a promising treatment for the alleviation of peripheral neuropathic pain. Following twelve weeks of treatment, the new formulation showed good tolerability in people diagnosed with diabetic peripheral neuropathy or postherpetic neuralgia.