FDA delays decision on Wyeth’s Pristiq
Wyeth said yesterday that the FDA will extend its review of Pristiq (desvenlafaxine succinate) to treat menopause symptoms until late July, several months later than expected.
The FDA was previously scheduled to issue a decision on Pristiq next week.
Wyeth said during an earnings call with analysts and investors on Thursday that the FDA postponed its decision on the drug so that regulators could review additional drug data submitted by Wyeth.
The new data show that lowering Pristiq’s dosage lessens side effects, including nausea, which could make the drug safer and more appealing to patients, Wyeth VP Joe Mahady said during the call.
Wyeth is also hoping to get FDA approval to market Pristiq as a treatment for depression in older women. But the FDA’s review of Pristiq for depression has also been delayed. If approved, marketing of Pristiq for depression won’t happen at least until the first part of 2008, Wyeth said.