FDA Issues Approvable Letter For Wyeth's Experimental Drug Pristiq To Treat Menopause Symptoms

26 Jul 2007 FDA on Monday issued an "approvable letter" for Wyeth's experimental drug Pristiq as a nonhormonal treatment for hot flashes and other menopause symptoms, an agency spokesperson said, the Wall Street Journal reports. According to the Journal, an approvable letter means that FDA could approve the drug but also usually means the agency needs more information before granting final approval (Corbett Dooren/Rubenstein, Wall Street Journal, 7/24).Pristiq is a new version of Wyeth's depression treatment Effexor, which will lose patent protection in 2010. Wyeth is seeking approval from FDA to market Pristiq as a depression treatment for older women, as well as a treatment for menopause symptoms (Kaiser Daily Women's Health Policy Report, 4/23). FDA spokesperson Rita Chappelle confirmed that the agency sent Wyeth the approvable letter but declined to provide additional information, the AP/Forbes reports (Perrone, AP/Forbes, 7/23). According to a Wyeth release, FDA in its letter said that before the application could be approved, Wyeth must provide additional data on the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq. The agency requested that these data come from a minimum one-year, randomized, placebo-controlled clinical trial conducted in postmenopausal women. In addition, FDA said that Wyeth must address certain chemistry, manufacturing and controls deficiencies prior to approval. FDA also made additional clinical and chemistry requests, which it said were not approvability issues, according to the release. "Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," Gary Stiles, executive vice president and chief medical officer at Wyeth, said, adding, "We will work with the agency to satisfy its requests for additional data and move the medicine forward in the FDA review process" (Wyeth release, 7/24). Wyeth said it plans to submit more data to FDA in the first quarter of 2008 in an effort to gain approval for Pristiq as a depression treatment, the Journal reports (Wall Street Journal, 7/24).