07.25.07
Wyeth received an approvable letter from the FDA for Pristiq, a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. However, the company needs to provide additional data regarding the potential adverse cardiovascular and hepatic effects associated with the use of Pristiq in this indication. The Agency requested a one-year clinical trial conducted in postmenopausal women. The FDA also requested that Wyeth address certain CMC (Chemistry, Manufacturing and Controls) deficiencies prior to approval.
"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 additional clinical studies prior to approval for this indication. The company plans to submit its complete response to the MDD approvable letter at the end of August, and the Agency is expected to render a decision in 1Q2008.
"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 additional clinical studies prior to approval for this indication. The company plans to submit its complete response to the MDD approvable letter at the end of August, and the Agency is expected to render a decision in 1Q2008.