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Lyrica DTC For Fibromyalgia “Consistent” With PhRMA Guidelines – Pfizer

Executive Summary

Pfizer will initiate direct-to-consumer advertising for Lyrica (pregabalin) for fibromyalgia this fall, approximately four or five months after the indication was approved, according to the firm

Pfizer will initiate direct-to-consumer advertising for Lyrica (pregabalin) for fibromyalgia this fall, approximately four or five months after the indication was approved, according to the firm.

During a second quarter earnings call, CEO Jeff Kindler highlighted the company's "fast-to-market strategy that will unleash a full array of sales and marketing resources, including DTC, within three months of FDA approval" as evidence that the firm's business restructuring efforts are paying off (1 (Also see "Pfizer’s U.S. Overhaul Is Paying Off, But Work Is Not Done – CEO Kindler" - Pink Sheet, 23 Jul, 2007.), p. 5).

Unbranded TV and print ads for the fibromyalgia indication, sponsored by the National Fibromyalgia Association and Pfizer, began running in July, shortly after the June approval (2 (Also see "Pfizer Launch Plans For Lyrica Fibromyalgia Approval Include Patient Groups" - Pink Sheet, 2 Jul, 2007.), p. 17).

The decision to move ahead so quickly with DTC is unusual in the pharmaceutical industry, which has faced criticism over its aggressive advertising strategies.

However, Pfizer maintains that the timeframe to launch the campaign is "consistent" with guidelines set by the Pharmaceutical Research and Manufacturers of America. The guidelines advise companies to "spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign."

The firm points out that Lyrica has been marketed since 2005, "and there is already a great deal of familiarity on the part of physicians with its safety and efficacy profile."

"In fact, more than 5 million prescriptions for Lyrica have been written worldwide," Pfizer told "The Pink Sheet." Pregabalin was first approved in December 2004 for management of postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy (3 (Also see "Pfizer Lyrica Launch Awaits Controlled Substance Scheduling" - Pink Sheet, 10 Jan, 2005.), p. 5).

In addition, "Pfizer began educating physicians quickly about the new fibromyalgia indication for Lyrica after it was approved, and is continuing to roll out our educational activities for specialists and primary care physicians," the firm said.

- Brooke McManus ([email protected])

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