Pfizer has reported top-line results from two placebo-controlled trials carried out in China with Lyrica (pregabalin) in patients with postherpetic neuralgia (pain after shingles or PHN) and painful diabetic peripheral neuropathy (pDPN), respectively.
The PHN Phase IV trial, A0081276, met its primary endpoint by showing a statistically significant reduction in pain when compared with placebo.
The eight-week, randomised, double-blind, multicentre, placebo-controlled, post-marketing PHN trial was designed to evaluate the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of PHN subjects.
For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed.
The safety profile in the PHN trial was consistent with the known profile for Lyrica.
PHN is a type of peripheral neuropathic pain caused by nerve damage and its symptoms include continued burning or electric shock-like pain.
Separately, the pDPN Phase III trial (A0081265) did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo.
The 11-week randomised, double-blind, multicentre, placebo-controlled pDPN trial was evaluating the efficacy, safety and tolerability of pregabalin 300mg/day to treat subjects with pDPN.
For the primary efficacy parameter, endpoint mean pain score, a treatment difference of -0.28 points for pregabalin relative to placebo was observed.
In the pDPN trial, the safety profile of pregabalin was consistent with the known profile for Lyrica.
The company said that complete results for both studies will be submitted for publication when analyses are complete.
Currently, Lyrica is approved for various indications in 120 countries and regions globally, while in China the drug is approved for PHN.