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Lyrica (pregabalin) for GAD approved in Europe

Posted by SLS on April 13, 2006, at 8:20:01


Pregabalin (Lyrica) for Generalized Anxiety Disorder in EU

On March 27, the European Commission (EC) approved a new indication for pregabalin (Lyrica capsules, made by Pfizer, Inc), allowing its use for the treatment of generalized anxiety disorder (GAD) in the European Union.

The approval was based on a review of data from 5 randomized, double-blind clinical trials in more than 2000 patients showing that pregabalin provided rapid and sustained efficacy in treating GAD, yielding significant relief from psychic and somatic symptoms within the first week of treatment.

The majority of adverse events related to pregabalin use were mild to moderate in intensity and generally dose-related. Dizziness and drowsiness were most frequently reported.

Pregabalin was previously approved by the EC and the US Food and Drug Administration for the management of diabetic peripheral neuropathy, postherpetic neuralgia, and adjunctive treatment of partial-onset seizures.

 

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