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Sunday, April 24, 2005

The Today Sponge Birth Control Is Back

Top Stories - Los Angeles Times
Sponge Birth Control Is Back

Sat Apr 23, 7:55 AM ET

By Thomas H. Maugh II Times Staff Writer

The Today Sponge, once the most popular female over-the-counter contraceptive in the country, is coming back on the U.S. market after 10 years in limbo.

The Food and Drug Administration has approved sale of the contraceptive and it will be available soon on the website of its manufacturer, Allendale Pharmaceuticals Inc.

Company president Gene Detroyer said Friday that the Today Sponge should be in stores this summer.

"Anytime the FDA approves a contraceptive method it is important," said Lawrence B. Finer of the Alan Guttmacher Institute, a research group that focuses on reproductive health. "The more methods there are, the better the chances that someone is going to find one that is a good fit for him or her. Anecdotally, we certainly hear that there is a demand."

The new version of the sponge has been on sale in Canada for two years, but its sale in the United States has been delayed by the company's difficulties in obtaining FDA approval for its manufacturing plant in Norwich, N.Y.

Similar problems led to the withdrawal of the Today Sponge in 1995. The safety of the device was not an issue.

An estimated 250 million Today Sponges were sold from 1983 to 1995. The contraceptive was popular among women because of its ease of use and the fact that it did not contain hormones. Data collected in 1995 indicated that 12% of American women 15 to 44 and 19% of those 30 to 34 had used the Today Sponge at some point.

In 1993, the FDA found that the Hammonton, N.J., plant used by American Home Products to manufacture the sponge and other products was using water contaminated with bacteria. The agency also questioned techniques for sterilizing equipment in the facility and laboratory methods used to test for contamination.

Rather than spend the money required to upgrade the facility, the company stopped selling the Today Sponge.

The decision was a blow to many women, depicted in an episode of the television show "Seinfeld" in which Elaine Benes scoured pharmacies to stock up on remaining supplies of the sponge. She then rationed her supply by putting prospective partners through a series of tests to determine whether they were "spongeworthy."

"I can tell you that many women are looking forward to the return of the sponge," said Dr. Anne Davis, an obstetrics- gynecology specialist at Columbia University. "It's important to have a variety of contraceptive options available to all women."

Allendale Pharmaceuticals was formed in the late 1990s to bring the Today Sponge back to the market and has been working to improve its manufacturing techniques. By nature, the device is more difficult to produce than a pill or liquid.

As the name implies, the product is a polyurethane sponge, but it contains the spermicide nonoxynol-9. The sponge gradually releases the spermicide while providing a physical barrier to block the passage of sperm, which are absorbed into its many crevices.

The product has shown an efficacy rate of 89% to 91%.

The product does not provide any protection against sexually transmitted diseases.

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