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Pfizer Phase 3 pregabalin study fails to meet primary endpoint

PBR Staff Writer Published 19 November 2012

Pfizer Phase 3 study of pregabalin controlled-release (CR) formulation has failed to meet the primary endpoint of reducing the frequency of seizures in epilepsy patients.

The double-blind, placebo-controlled, randomized study was designed to evaluate the safety and efficacy of 165mg and 330mg doses of pregabalin as an adjunctive therapy for epilepsy patients with partial onset of seizures.

Although both the doses were well tolerated in the study, a non-significant result between pregabalin and placebo was reported.

Pfizer global primary care business unit medicines development group head, senior vice president Steven Romano said the lack of a statistically significant improvement may have been due to a higher-than-expected response among patients taking the placebo.

"Lyrica immediate-release has a proven success record in patients with epilepsy, and we look forward to understanding further the potential role of a once-a-day pregabalin formulation," Romano added.

The multi-center study is one of the three Phase 3 studies designed to evaluate the potential use of pregabalin as a once-a-day therapy.

Pregabalin CR formulation is being assessed in fibromyalgia and post-herpetic neuralgia patients in other two studies.

 

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