Pfizer's Lyrica gets CHMP nod as GAD drug

World-leading drug major Pfizer says it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding its anxiety disorder drug Lyrica (pregabalin). The EMEA will consider the committee's recommendations and anticipates making the final regulatory approval decision in the next few months.

According to Pfizer, generalized anxiety disorder is a psychiatric problem characterized by excessive worry and physical symptoms such as fatigue, poor sleep regulation and irritability which affects an estimated 5% of people during their lives. The drugmaker adds that GAD-related health care costs in Europe are estimated at approximately $1.5 billion per year.

Lyrica, which has already gained regulatory approval for several neuropathic pain indications, and as an adjunctive therapy for epilepsy in more than 50 countries outside the USA, is an alpha-2-delta ligand, believed to have a calming effect on hyper-excited neurons associated with both GAD and generalized neuropathic pain.