Pfizer Inc Reports Top-Line Results Of EU Post-Authorization Safety And Efficacy Study Of Lyrica’s Discontinuation Effects In Patients With Generalized Anxiety Disorder

Pfizer Inc announced top-line results for Lyrica (pregabalin) capsules Study A0081147 – Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) – demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients. The objective of the double-blind, placebo- and active-controlled study was to characterize the safety and efficacy of Lyrica lower dosage (150 mg/day – 300 mg/day) and higher dosage (450 mg/day – 600 mg/day) and lorazepam (4 mg/day) compared to placebo following three months and six months of treatment. A total of 621 patients, 615 of whom received at least one dose of study drug, were randomized and treated at 60 centers in 16 countries. The primary endpoints of the study were met. Efficacy endpoints were the Hamilton Anxiety Rating Scale (HAM-A) total score and Clinical Global Impressions – Severity and Improvement scale (CGI-S). The results confirm that in a large, prospective placebo controlled study, discontinuation of Lyrica was well tolerated compared with placebo. Results demonstrated efficacy was maintained after three months, with a slight continued improvement in patients up to six months of treatment; these are generally consistent with those demonstrated in the Phase 3 registration trials.