BizJournals Portfolio
Dec 24 2009 9:24am EDT

Lump of Coal for Pfizer

There's no present under the tree for Pfizer Inc.

The Food and Drug Administration rejected the drug maker's application to expand usage of its epilepsy medicine Lyrica for treatment of general anxiety disorder, a move that would've provided the company with a much-needed new source of revenue.

The agency told the company that it had insufficient data to approve Lyrica as a single treatment for the condition. Pfizer is still waiting to hear about another application that would allow it to market Lyrica as a drug used in combination with other medicines.

Big pharma is struggling to find new revenue. Pfizer is trying to juice sales as it faces the loss of patent protection on big drugs, most notably Lipitor in 2011. Sales of Lipitor fell 11 percent through the first nine months of the year to $8.3 billion.

Lyrica is another big drug for Pfizer. It had sales of $2 billion through nine months this year, an 8 percent rise over the year-earlier period.

In a statement, the New York-based company voiced its disagreement with the agency's decision.

“Given the chronic nature of (general anxiety disorder) and the number of patients who continue to experience anxiety symptoms despite treatment, there is a clear unmet need for new and different treatment options,” says Pfizer Vice President Steve Romano, who is the medical affairs head for the drug maker's primary care business unit.


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