To quell the speculation, Wyeth's chief scientist, Bob Ruffalo, and chief medical officer, Gary Stiles, spent nearly an hour late this afternoon explaining in slightly greater detail their view of cardiovascular and liver side-effect issues that worry the FDA. Bottom line, says Ruffalo, is that Wyeth believes Pristiq doesn't present a safety risk. "The safety profile is sound," says Stiles.
Nonetheless, the agency wants a new, year-long trial, which won't wrap up until the end of 2008. That's a big delay. And there's still no assurance Pristiq will get approved for hot flashes. Meanwhile, Ruffalo says he's "confident" Pristiq will be approved for depression early next year. They need to be right: the Effexor antidepressant is far and away Wyeth's biggest seller - last year, sales were $3.7 billion - but the patent expires in 2010.