Pfizer Inc. (NYSE: PFE) announced today that 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 European Medicines Agency (EMA) requested this study to investigate the relationship between dose and duration of treatment on discontinuation symptoms, including rebound anxiety, following long-term treatment with Lyrica in GAD patients. Pfizer will continue to further analyze these top-line results.
Lyrica is approved for the treatment of GAD in adults in the European Union and several other regions around the world, but not in the United States.
GAD is a chronic, debilitating illness characterized by excessive anxiety and worry for at least six months in duration. Often lasting longer than five years, GAD symptoms are both psychological (anxious mood, heightened fears, feelings of tension, difficulty concentrating) and physical (fatigue, pain, feelings of weakness, gastrointestinal disturbance, palpitations, sleep disturbance and restlessness).