Wyeth's "No-Period" birth control pill awaits FDA approval

The U.S. Food and Drug Administration (FDA) is expected to give its nod to Lybrel, a birth control pill that also frees women of their monthly menstrual period. If approved, Lybrel, manufactured by Wyeth, will be the fourth such drug following Yaz and Loestrin 24, which shorten menstrual periods to less than three days and another drug called Seasonique, which limits periods to just four times in a year.

Lybrel, which is awaiting approval from the FDA, could be the first pill to be taken continuously instead of the standard schedule of 21 daily active pills, followed by seven sugar pills. It is also the first pill specifically designed to eliminate the fertility cycle, which many regard as central to womanhood.

According to Wyeth Pharmaceuticals, the leader in manufacturing estrogen replacements, Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel. This drug is supposed to reduce some 17 symptoms related to periods including bloating and irritability, Wyeth said.

"If approved Lybrel would be the first and only continuous oral contraceptive," said Wyeth spokeswoman Danielle Halstrom. "Lybrel is intended for women who are seeking contraception and who are seeking to put their menstrual cycle on hold."

In testing of Lybrel, 59 percent of women ended up with no bleeding after six months, while 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, Wyeth said.

US drug watchdog, FDA is all set to license Lybrel after trials showed it had no significant side effects. Although FDA is not bound to follow its advisory panel's recommendations, it generally follows their guidance. The health agency makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

Dr Leslie Miller, a gynecologist at the University Of Washington-Seattle who has carried out studies on women and periods, said that women frequently ask their doctors about how to limit or stop their monthly bleeding from their period. Wyeth’s Lybrel could be the first solution for them to get what they want.

Several health experts say there's no medical reason women need monthly bleeding and believe it causes health problems in women, including anemia and epilepsy, while others believe blocking periods could be unsafe in the long term. Women are still ambiguous whether blocking periods is safe or natural.

Surveys show up to half of women would prefer not to have any periods, most would prefer them less often and a majority of women take prescribed contraceptive pills to reduce the side effects.

Analysts have estimated Lybrel sales could reach $40 million this year and $235 million by 2010. U.S. sales of Seasonique, which allows a woman to skip her period for three months, hit $6.1 million in the first quarter of 2007. Launched last year in August, Seasonique sales rose nearly 40 percent from 2005 to 2006, to $120 million, according to its manufacturer, Barr Laboratories.

Predecessor Seasonale, which got cheaper generic competition in September, peaked at about $100 million. Yaz, introduced last August by Berlex, had first-quarter sales of $35.6 million, while Loestrin 24, launched in April 2006, hit $34.4 million in the first quarter.

Shares of Wyeth hit a 52-week high of $58.49 on Monday, surpassing a previous high of $57.59 on nearly four times their average volume.

Lybrel, a potential name-brand prescription drug, could hit markets in July, but Wyeth has said it intends to market it among doctors first.

FDA is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States.