GAD
Pregabalin Receives a Positive Opinion from CHMP for the Treatment of Generalized Anxiety Disorder in Adults
By Pfizer
Jan 28, 2006 - 12:37:00 PM

Pfizer Inc said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending marketing authorization of Lyrica� (pregabalin), a novel mechanism for the treatment of generalized anxiety disorder (GAD) in adults.

The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union. Pfizer anticipates a final decision from the Commission in the coming months.

"Though GAD has been formally recognized by the medical community and is frequently associated with high levels of distress and impairment, the condition often goes undetected and untreated," said Dr. Joseph Feczko, Pfizer's chief medical officer. "It is estimated that only one-third of those who suffer from this condition seek treatment despite the significant impact on patient quality of life. We are pleased that the CHMP has recognized the potential therapeutic benefits of Lyrica in treating this serious medical condition."

GAD, which affects an estimated five percent of people at some point in their lives, is a psychiatric disorder characterized by excessive worry as well as physical symptoms such as poor sleep, fatigue, difficulty concentrating, irritability and restlessness. GAD affects slightly more women than men, and symptoms are often chronic and worsen during times of stress. GAD occurs more frequently in patients with chronic medical illnesses, particularly in connection with pain syndromes. The direct annual healthcare costs associated with GAD in Europe are approximately $1.5 billion.

"Despite frequent visits to their doctor, GAD patients are still very poorly treated." said Dr. Stuart Montgomery, Professor of Psychiatry, Imperial College School of Medicine, University of London. "The psychological and physical effects of GAD disrupt work and personal relationships and make it difficult to carry on with everyday activities. Accurate diagnosis of GAD is important since prolonged anxiety increases impairment and worsens the outcome of co-existing physical illnesses."

Lyrica has been approved for various neuropathic pain indications including peripheral neuropathic pain, diabetic and postherpetic neuropathic pain and adjunctive therapy for epilepsy in more than 50 countries outside of the United States. The most common adverse events in Lyrica's clinical development program were dizziness and somnolence. In the U.S., Lyrica� (pregabalin) capsules C-V is FDA approved for the management of diabetic peripheral neuropathy, postherpetic neuralgia and adjunctive treatment of partial onset seizures. Developed by Pfizer, Lyrica is an alpha-2-delta ligand that is believed to work by calming hyper-excited neurons.

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