Wyeth Gets Approvable Letter for Pristiq

Wyeth said the U.S. Food and Drug Administration has asked for one more clinical trial before clearing Pristiq for treating menopause symptoms.

The FDA apparently has concerns about the safety of Pristiq because the agency’s approvable letter requested additional data regarding the drug’s potential for serious adverse effects on the heart and liver.

Wyeth, which is developing Pristiq as a treatment for hot flashes and night sweats associated with menopause, said it remains committed to the development of the drug.

We will work with the agency to satisfy its requests for additional data and move the medicine forward in the FDA review process, said Gary Stiles, Wyeth’s executive vice president and chief medical officer.

This is the second approvable letter Wyeth has received for Pristiq. The FDA in January rejected Pristiq as a treatment for major depressive disorder. Wyeth has said it plans to submit its response to that approvable letter in August.