Pfizer has reported positive results from a double-blind, Phase 3 study of pregabalin controlled-release (CR) formulation as treatment for fibromyalgia patients.
According to the study data, pregabalin CR demonstrated a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR).
Pfizer global primary care business unit, medicines development group, head and senior vice president Steven Romano said the results from controlled release studies will help in better understanding of the potential of a once-a-day pregabalin treatment regimen.
"Reducing the number of times patients need to take their medicine per day while maintaining the same efficacy and safety profile could potentially provide a greater convenience and the potential to enhance treatment adherence and outcomes," Romano added.
The placebo-controlled, multi-centre study composed of 4 phases was designed to evaluate the efficacy and safety profile of pregabalin CR as treatment for fibromyalgia patients.
Primary end-point, time to LTR during DB, occurred in 34 of 63 (54.0%) patients in the pregabalin group as compared with 41 of 58 (70.7%) subjects in the placebo group.
The study reported a 58-day median time from randomisation to LTR in the pregabalin group and 22 days in the placebo group, as well as observed statistically significant difference between the treatments.
Pregabalin CR, which was well tolerated in the study, demonstrated a safety profile similar to the identified profile for pregabalin (immediate release) in fibromyalgia patients.
Dizziness, somnolence, peripheral edema, insomnia, headache, fatigue, nausea, weight increased, vision blurred, dry mouth and disturbance in attention were adverse events reported in 5% or more of study’s subjects.
Image: Pfizer pregabalin CR formulation showed positive effect compared to placebo in Phase 3 fibromyalgia study. Photo: courtesy of Jim.henderson.
