Global pharma behemoth Pfizer (NYSE: PFE) has announced top-line results from a Phase III study showing its neuropathic pain drug Lyrica (pregabalin) controlled release was as effective as levetiracetam (UCB’s now off-patent epilepsy drug Keppra) as an adjunctive therapy in adult epilepsy patients experiencing refractory partial onset seizures.
The top-line results indicate that the study met its primary endpoint by demonstrating that a comparable proportion of patients on Lyrica achieved at least a 50% reduction in the 28-day seizure rate during the maintenance phase relative to levetiracetam. The adverse event profile in the study was consistent with that known for Lyrica, which, following the loss of patent exclusivity for Lipitor (atorvastatin) is now Pfizer’s top-selling drug with 2012 sales of $4.16 billion.
The new results are a positive for the drug, as last year Pfizer reported disappointing findings from a Phase III study in adult patients with partial onset seizures with epilepsy (The Pharma Letter November 20, 2012). These indicated that pregabalin CR did not meet its primary endpoint comparing the change in seizure frequency to placebo, although the two doses tested were well-tolerated.
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