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Published on 3/27/2006 in the Prospect News Biotech Daily.

Pfizer's Lyrica approved for anxiety disorder treatment in Europe

By Elaine Rigoli

Tampa, Fla., March 27 - Pfizer, Inc said Monday that the European Commission has approved Lyrica (pregabalin) for the treatment of generalized anxiety disorder in adults.

In the European Union, it is estimated that nearly 12 million patients suffer from generalized anxiety disorder on a yearly basis, yet only one-third of these patients are properly diagnosed and even fewer received effective treatment, according to a news release.

Lyrica's approval was based on five randomized, double-blind clinical trials involving more than 2,000 patients. Data from a combination of five placebo-controlled studies demonstrate that Lyrica provides rapid and sustained efficacy for the treatment of generalized anxiety disorder, the release said.

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, the release said.

The direct annual health care costs associated with generalized anxiety disorder in Europe are about $1.5 billion.

Pfizer said Lyrica has been approved in more than 60 countries outside of the United States. In the United States, Lyrica is 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.

Pfizer is an international pharmaceutical company with headquarters in New York.


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