Biopharmaceuticals Regulatory

 News Release - March 27, 2006

Pfizer's Lyrica Approved for the Treatment of Generalized Anxiety Disorder (GAD) in Europe

An estimated 12 million patients in Europe suffer from generalized anxiety disorder, a common and chronic psychiatric disorder characterized by excessive worry and tension

UK Expert: 'New treatment option to help alleviate a broad range of emotional and physical symptoms'

NEW YORK, March 27 (HSMN NewsFeed) -- Pfizer Inc said today that the European Commission has approved Lyrica® (pregabalin) for the treatment of generalized anxiety disorder (GAD) in adults. In the European Union, it is estimated that nearly 12 million patients suffer from GAD on a yearly basis yet only one-third of these patients are properly diagnosed and even fewer received effective treatment.

Lyrica'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.

"GAD is much more than the normal anxiety people experience under times of stress. It is a chronic, debilitating illness that can greatly disrupt an individual's daily life, yet the disorder is under-treated," said Dr. Stuart Montgomery, Professor of Psychiatry, Imperial College School of Medicine, University of London. "Now that Lyrica is available, we have a new treatment option to help alleviate a broad range of emotional and physical symptoms of this prevalent condition."

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.

"Lyrica represents an innovative treatment advance for patients suffering from generalized anxiety disorder," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "Early diagnosis and effective treatment is critical since prolonged anxiety increases impairment and worsens the outcome of co-existing illnesses."

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.

Source: Pfizer

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