Wyeth Receives Approvable Letter From FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated With Menopause
Collegeville, Pa.– Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for PRISTIQ™ (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
In its letter, the FDA said that before the application could be approved, it would be necessary for Wyeth to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of PRISTIQ in this indication. The Agency requested that these data come from a randomized, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women. The Agency also requested that Wyeth address certain CMC (Chemistry, Manufacturing and Controls) deficiencies prior to approval.
The FDA also made additional clinical and chemistry requests, which the Agency stated were not approvability issues.
“Wyeth remains committed to the development of PRISTIQ as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause,” says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. “We will work with the Agency to satisfy its requests for additional data and move the medicine forward in the FDA review process.”
On January 22, 2007, the Company received an approvable letter for PRISTIQ for the treatment of Major Depressive Disorder (MDD), which did not require submission of additional clinical studies prior to approval for this indication. As previously announced, Wyeth intends to submit its complete response to the MDD approvable letter at the end of August, and the Agency is expected to act on the application during the first quarter of 2008.
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