Lyrica pregabalin: Phase IV data

Pfizer reported top-line data from the double-blind, placebo- and active-controlled, international Phase IV A0081147 trial in 621 patients with GAD showing that drug discontinuation symptoms were low after tapering Lyrica following 3 and 6 months of treatment and that discontinuation of Lyrica was well tolerated compared to placebo. The pharma also said that Lyrica met the primary efficacy endpoints of improving HAM-A total score, CGI-S and CGI-I scores, but did not disclose details. Patients received placebo, lorazepam or low- (150-300 mg/day) or high-dose (450-600 mg/day) Lyrica. Pfizer said EMA requested the study to investigate the relationship between dose and duration of treatment on discontinuation symptoms, including rebound anxiety, following long-term treatment of GAD with Lyrica. ...