The European Commission has approved Pfizer’s Pregabalin for the treatment of generalized anxiety disorder (GAD) in adults.

It is estimated that nearly 12 million patients suffer from GAD on a yearly basis in the European Union, yet only one-third of these patients are properly diagnosed and even fewer received effective treatment.

Named Lyrica, the drug’s approval was based on five randomized double-blind clinical trials involving over 2,000 patients. Data from a combination of five placebo-controlled studies demonstrate that Lyrica provides rapid and sustained efficacy for the treatment of GAD.

As early as the first week of treatment, Lyrica was shown to be significantly effective in providing relief of both emotional symptoms, such as depressive symptoms and panic, as well as physical symptoms, including headaches and muscle aches.

Generalized anxiety disorder, which affects an estimated five percent of people at some point in their lives, is a common and chronic psychiatric disorder characterized by excessive worry and tension about everyday routine life events and activities. Physical symptoms include poor sleep and fatigue, while the emotional symptoms include difficulty concentrating, irritability and restlessness.
Generalized anxiety disorder occurs more frequently in patients with other chronic medical illnesses, especially those associated with pain conditions. The direct annual healthcare costs associated with GAD in Europe are approximately $1.5 billion.

The most common adverse events reported by patients were dizziness and drowsiness. Most adverse events were mild to moderate in intensity and generally dose related.

In the United States, Lyrica (pregabalin) C-V capsules are approved for the management of diabetic peripheral neuropathy, post herpetic neuralgia and adjunctive treatment of partial onset seizures. Lyrica is an alpha-2-delta ligand that is believed to work by calming hyper-excited neurons.

Developed by Pfizer, Lyrica has been approved for various neuropathic pain indications including peripheral neuropathic pain, diabetic and post herpetic neuropathic pain and adjunctive therapy for epilepsy in more than 60 countries outside of the United States.