Pfizer's Lyrica gets positive opinion from European Medicines Agency committee

By Lisa Kerner

Erie, Pa., Jan. 27 - Pfizer Inc. said 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 in adults.

The committee's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union, according to a company news release.

Pfizer said it anticipates a final decision from the commission within the next few months.

Lyrica is an alpha-2-delta ligand that is believed to work by calming hyper-excited neurons.

Generalized anxiety disorder is a psychiatric disorder characterized by excessive worry, poor sleep, fatigue, difficulty concentrating, irritability and restlessness. The direct annual health care costs associated with generalized anxiety disorder in Europe are about $1.5 billion, the company said.

Lyrica has been approved for various neuropathic pain indications and for adjunctive therapy for epilepsy in more than 50 countries outside of the United States. In the United States, Lyrica capsules C-V is approved by the Food and Drug Administration for the management of diabetic peripheral neuropathy, postherpetic neuralgia and adjunctive treatment of partial onset seizures.

New York-based Pfizer discovers, develops, manufactures and markets prescription medicines

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