FDA Approves Wyeth's Experimental Drug Pristiq To Treat Menopause Symptoms

FDA on Monday issued an "approvable letter" for Wyeth'sexperimental drug Pristiq as a nonhormonal treatment for hot flashesand 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 alsousually means the agency needs more information before granting finalapproval (Corbett Dooren/Rubenstein, Wall Street Journal, 7/24).

Pristiqis a new version of Wyeth's depression treatment Effexor, which willlose patent protection in 2010. Wyeth is seeking approval from FDA tomarket Pristiq as a depression treatment for older women, as well as atreatment for menopause symptoms (Kaiser Daily Women's Health Policy Report,4/23). FDA spokesperson Rita Chappelle confirmed that the agency sentWyeth the approvable letter but declined to provide additionalinformation, 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 adversecardiovascular 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 inpostmenopausal women. In addition, FDA said that Wyeth must addresscertain chemistry, manufacturing and controls deficiencies prior toapproval. FDA also made additional clinical and chemistry requests,which it said were not approvability issues, according to the release.

"Wyethremains committed to the development of Pristiq as a potentialtreatment for moderate-to-severe vasomotor symptoms associated withmenopause," Gary Stiles, executive vice president and chief medicalofficer at Wyeth, said, adding, "We will work with the agency tosatisfy its requests for additional data and move the medicine forwardin the FDA review process" (Wyeth release, 7/24). Wyeth said it plansto submit more data to FDA in the first quarter of 2008 in an effort togain approval for Pristiq as a depression treatment, the Journal reports (Wall Street Journal, 7/24).
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