Pfizer's ability to reach what may be an untapped population of people suffering from fibromyalgia got a boost last week when Lyrica became the first FDA-approved therapy for the condition.

Fibromyalgia, which the FDA says affects about 3 to 6 million people in the US annually, is viewed as an important indication. Some analysts say it could add as much as a billion dollars to sales. Now that the company can begin urging patients with the disorder to speak with their doctors about Lyrica—four months earlier than expected, thanks to priority review—it may place a bigger emphasis on DTC.

Pfizer declined to comment about its advertising plans. "There are several things we're considering, but we haven’t made any firm decisions at this point," a spokesman told MM&M.

Driving awareness of the condition, whose symptoms can include debilitating pain, sleep problems, stiffness and fatigue, is sure to be a key theme.

"Demand in fibromyalgia is something that will be more patient-driven than physician-driven," observed Barbara Ryan, an analyst with Deutsche Bank. "The ability to advertise directly to consumers, at least in this particular indication, would be important."

While the FDA says there is no test to confirm a diagnosis, clear diagnostic criteria for fibromyalgia were established in 1990 by the AmericanCollege of Rheumatology. Awareness is low, however.

“The issue is that a lot of physicians and patients themselves don’t actually know about those diagnostic criteria,” the Pfizer spokesman said. “Right now it’s been something that’s been discussed and taught about in the specialist communities but not necessarily in the broader primary care communities.”

Studies have shown that some patients have decreased pain after taking Lyrica (pregabalin), but the mechanism by which the drug produces such an effect is unknown.

Pfizer plans to launch the indication to physicians in the third quarter but would not reveal its DTC timeline. The Lyrica consumer ad account resides with Kaplan Thaler, while Euro RSCG Life LM&P handles professional. Both declined to comment.

Reaching consumers won’t come cheap. In 2006, Lyrica’s first full year on the US market, Pfizer spent $27.5 million promoting the drug to consumers for its other indications: nerve pain associated with diabetes and shingles, as well as partial onset seizures. Lyrica was approved in late 2004 but didn't launch until the following September due to a delay in getting classification from the Drug Enforcement Agency (the product is a controlled substance). According to Nielsen Monitor-Plus, in the first quarter of this year, the DTC budget was $12.1 million.

Meanwhile, analysts are having difficulty sizing the market the new indication may open up, because they can’t gauge the extent to which existing fibromyalgia patients already were being treated with products like Lyrica that have pain indications, or how much of Lyrica’s use had been for this population. Thus far doctors have been treating it with a mixture of painkillers and antidepressants.

Lyrica had $1.2 billion in 2006 sales. Prudential analysts forecast $1.6 billion in US sales this year, growing to $2.7 billion by 2012. Deutsche Bank, for which Pfizer is an investment banking client, pegged 2008 earnings at $1.7 billion and thinks the fibromyalgia market alone could be worth another billion dollars.

“We are at least forecasting [Lyrica] will have strong sales growth over the next several years in the 20-40% range,” said Ryan, who had anticipated the new indication and so had already been factoring it into estimates. “We’ll have to watch the data.”