Today Sponge approved for sale
The Today Sponge, once the most popular female over-the-counter contraceptive in the United States, is coming back on the 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 Web site of Allendale Pharmaceuticals Inc., its manufacturer.
Company president Gene Detroyer said Friday the Today Sponge should be available in stores this summer.
“Anytime the FDA approves a contraceptive method it is important,” said Lawrence B. Finer of the Alan Guttmacher Institute, a reproductive research group. “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.
It was similar problems with the manufacturing facilities that led to its withdrawal of the Today Sponge in 1995. The safety of the device was not an issue.
An estimated 250 million Today Sponges were sold between 1983 and 1995. The contraceptive was very popular with women because of its ease of use and the fact that it did not contain any hormones. Data collected in 1995 indicated that 12 percent of American women ages 15 to 44, and 19 percent of those 30 to 34, had used the Today Sponge at some point.
But 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 the company’s techniques for sterilizing equipment in the facility and the laboratory techniques used to test for contamination.
Rather than invest the money required to upgrade the facility, the company stopped selling the Today Sponge.
The decision was a blow to many women, entering the popular culture in a well-known episode of the television show, “Seinfeld,” in which Elaine Benes scoured pharmacies to stock up on their remaining supplies of the Sponge. She then rationed her supply by putting prospective lovers 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 ob-gyn 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 ever since to perfect its manufacturing techniques.
As the name implies, the product is a polyurethane sponge, but it is impregnated with 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 does not provide any protection against sexually transmitted diseases, however.