After an absence of more than 10 years, the Today Sponge contraceptive has been cleared for return to the U.S. market.
The sponge gained pop culture status when the TV show character Elaine of "Seinfeld" hoarded sponges after they went off the market, devoting them only to men she deemed "spongeworthy."
"We're very, very pleased to bring it back to women in the U.S.," says Bob Staab, PhD, chairman and chief scientific officer for New Jersey-based Allendale Pharmaceuticals. "It's been a long road to get there," he tells WebMD.
FDA spokeswoman Susan Cruzan confirmed U.S. approval.
Look for It Soon
Staab says the company is currently working to build inventory for the U.S. market and predicts that shipping to stores may begin in "a handful of months."
The sponge will also be sold over the Internet to U.S. consumers, says Staab, noting that the sponge does not require a prescription.
The sponge has been sold in Canada and over the Internet to Canadian consumers for a year-and-a-half, says Staab.
There have been "no incidents of things such as toxic shock syndrome" during that time, says Staab. "There have been no effectiveness or safety issues. It is safe and effective and always was."
Sponge Absent in U.S. for 11 Years
American Home Products (now Wyeth) -- former maker of the sponge -- stopped production in March 1994. The company "had manufacturing problems," says Cruzan.
American Home Products decided not to upgrade the plant where the sponge was made after the FDA pointed out the problems, says an FDA statement from January 1995.
Allendale Pharmaceuticals bought the rights to the sponge at the end of 1998. "We've done a lot of upgrades to the equipment, plant, chemistry, and procedures to come out with a product that's safe and effective," says Staab.
The sponge's basic safety and effectiveness were never in question; only manufacturing approval was needed for production to resume.
The sponge is 89%-91% effective, says Staab, calling the rate "very, very good."
"What that really means is about 1,000 acts of intercourse before a pregnancy takes place," he tells WebMD. Staab says the sponge is "completely reversible, nonsystemic, nonhormonal" and provides up to 24 hours of contraception for spontaneous multiple acts of intercourse.
He says the sponge works equally well for women who have had children before and those who haven't and has been tested by Allendale Pharmaceuticals in clinical studies on nearly 2,000 women.
"Couples in the U.S. who choose to use contraception need more choices," says Staab.
However, unlike condoms, the sponge does not protect against sexually transmitted diseases. And the sponge is not as effective as birth control pills. When taken correctly, birth control pills are up to 99.9% effective.