FDA tells Wyeth drug approvable for hot flashes

Last Updated: 2007-07-24 12:00:50 -0400 (Reuters Health)

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Monday it had sent an "approvable letter" to Wyeth, which is seeking to sell a new drug to treat women with hot flashes from menopause.

" Wyeth received an approvable letter for Pristiq," said an FDA spokeswoman in a brief statement.

An approvable letter means the FDA will clear a drug for sale once certain conditions are met. The FDA typically does not disclose the conditions.

A Wyeth spokesman confirmed the company had received the letter, but had no immediate comment on its content. Wyeth has scheduled a conference call to discuss the drug at 8 a.m. (1200 GMT) on Tuesday.

Pristiq, is the first non-hormonal treatment for hot flashes, a condition affecting an estimated 23 million American women.

The drug also is under FDA review as a possible treatment for depression. Like Wyeth's widely used antidepressant Effexor, Pristiq is in the family of drugs called serotonin-norepinephrine reuptake inhibitors that work on two brain chemicals.

Pristiq is considered one of the most important drugs in Wyeth's pipeline of experimental medicines.

If approved for both hot flashes and depression, industry analysts are expecting Pristiq to garner eventual annual sales of perhaps $2 billion -- helping to offset plunging sales of Effexor once the $3.5 billion-a-year blockbuster faces generic competition by 2010.

Wyeth also sells the Premarin line of estrogen hormone replacement drugs that treat hot flashes. But sales of the medicines fell sharply after a U.S. government-financed study linked them to increased risk of breast cancer.

"For many women, hormone replacement therapy just isn't an option because of the perceived health risk, so for these people Pristiq is a good choice," said Linda Bannister, an analyst with Edward Jones.

Pristiq's generic name is desvenlafaxine.

(Reporting by Lisa Richwine, and Ransdell Pierson)