Pfizer Phase III study of pregabalin controlled-release (CR) formulation has met primary endpoint of time to loss of therapeutic response (LTR), in fibromyalgia patients.
The primary endpoint of the placebo-controlled, multi-center study was achieved in 54% patients administered with pregabalin, compared to 70.7% patients in the placebo group.
A statistically significant difference between the treatments was observed in the study in which pregabalin was well tolerated.
Study reported median time from randomization to LTR of 58 days in pregabalin group and 22 days in the placebo group.
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 randomized, double-blind study is the second of the three Phase III studies designed to assess the potential use of pregabalin as once daily therapy.
First one conducted in adults with partial onset seizures with epilepsy failed to meet the goal while the third one in post-herpetic neuralgia is going on.