Published on May 5, 2012 at 12:46 AM
Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 randomized
withdrawal design study for Lyrica (pregabalin) in patients with
inadequately treated painful diabetic peripheral neuropathy (pDPN) did
not meet its primary efficacy endpoint, change in endpoint mean pain
score relative to baseline. The study, A0081242, is a Phase 3b
Multicenter, Double-Blind, Randomized Withdrawal Efficacy and Safety
Study of Pregabalin in the Treatment of Patients with Inadequately
Treated Painful Diabetic Peripheral Neuropathy.
Patients who had inadequate pain control while receiving a medication
for pDPN were switched to Lyrica (150 or 300 mg/day) during a 6-week
single-blind phase. Patients with ≥30% pain improvement were randomized
to receive placebo or to continue treatment with Lyrica for the 13-week
double-blind treatment phase.
665 patients received Lyrica in the single-blind phase of the study and
had an improvement in single-blind endpoint mean pain score relative to
baseline of 2.2 points (0-10 scale). Of the 294 patients who had
≥30% pain response and were randomized, Lyrica-treated patients had a
total improvement in endpoint mean pain score of 3.9 points relative to
baseline; however, this was not statistically significant compared to
placebo (3.5 point total improvement). Further analyses will be
conducted on these initial results.
The results for this study indicate that the most common adverse events
in Lyrica-treated patients were peripheral edema, dizziness, somnolence
and upper respiratory tract infection when compared with placebo. The
adverse event profile is consistent with that known for Lyrica.
Source: Pfizer Inc.