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FDA approves Pfizer's Lyrica for the treatment of the two most common forms of neuropathic pain

PHN. Lyrica provided rapid and clinically meaningful pain reduction in a significant portion of patients, with pain relief beginning as early as the first week of treatment in some patients. Pain relief was sustained in studies of up to 12-weeks duration.

The safety of Lyrica was established in over 9,000 patients. In all clinical trials, adverse events were mild to moderate. The most common side effects associated with Lyrica compared with placebo included dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain and difficulty with concentration/attention. The discontinuation rate due to side effects was low.

Lyrica is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse relative to controlled substances in other categories.

Lyrica is currently under review by the FDA for the adjunctive treatment of partial seizures in adults. In July, Pfizer received European Commission approval to market Lyrica in European Union member states for the treatment of peripheral neuropathic pain and as adjunctive therapy for partial seizures.


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Contact: Rebecca Hamm
212-733-8811
Burson-Marsteller
7-Jan-2005


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