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news.Pfizer has reported that Phase III randomized withdrawal design study for Lyrica (pregabalin) in painful diabetic peripheral neuropathy (pDPN) patients has failed to meet its primary efficacy endpoint.
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The change in endpoint mean pain score relative to baseline is the primary efficacy endpoint in the A0081242 study.
In the double-blind, randomized withdrawal efficacy and safety study, 665 patients received Lyrica in the single-blind Phase of the study and showed an improvement in single-blind endpoint mean pain score relative to baseline of 2.2 points (0-10 scale).
Of the 294 Lyrica-treated patients, who had =30% pain response and were randomized, had a total improvement in endpoint mean pain score of 3.9 points relative to baseline, which was not statistically significant compared to placebo.
The company expects to conduct further analyses on the initial results.
Peripheral edema, dizziness, somnolence and upper respiratory tract infection were the most common adverse events observed in Lyrica-treated patients when compared with placebo.