TRENTON, N.J. – The contraceptive that spawned a "Seinfeld" episode about "spongeworthy" men is returning to the U.S. market.
Allendale Pharmaceuticals said Friday the Food and Drug Administration has approved U.S. sales of the Today Sponge (search), the favorite nonprescription birth control product of women when it was withdrawn from the market in 1995.
"The product was found to be safe and effective," FDA (search) spokeswoman Susan Cruzan said.
The polyurethane sponges, which have been sold in Canada and over the Internet since March 2003, will be available in two months on a company Web site and later at retailers.
"I'm overwhelmed," Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals (search), told The Associated Press. "I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women."
Allendale bought rights to sell the Today Sponge years ago from American Home Products, which is now Wyeth of Madison. American Home stopped making the sponge rather than upgrade a manufacturing plant where the FDA found deficiencies.
The effectiveness and safety of the original product were never questioned, but the new version still required extensive testing before it could receive FDA approval.
The fierce loyalty of sponge fans was depicted in hilarious fashion on the sitcom "Seinfeld," which had the character Elaine Benes scouring stores for her favorite birth control, then stretching her supply by setting "spongeworthy" standards for prospective lovers.
The soft, concave Today Sponge prevents pregnancy by covering the cervix and releasing spermicide. Roughly 250 million of the sponges were sold from 1983 to 1995, and women favored it because it was easy to obtain and use.
However, it does not protect against sexually transmitted diseases and is far less effective as birth control than oral contraceptives, Depo-Provera injections or an intrauterine device. According to packaging information approved by the FDA, 13 percent to 16 percent of women using the Today Sponge would get pregnant in a year of typical use.
Allendale plans an advertising campaign for the U.S. market and expects sales to jump to 10 million to 15 million sponges in the first 12 months, Detroyer said. That's the current production limit of the company's factory in Norwich, N.Y., but the company has plans to double that.
The company had hoped to get the sponge back on the U.S. market shortly after getting rights to the product in 1998. Partly because the product is much more difficult to manufacture than a pill or liquid, they encountered setbacks as they sought FDA approval.
FDA allowed the company to make the product for sale in Canada two years ago. There, the product is classified as a medical device; FDA classifies it as a drug, requiring a more rigorous approval process.
Longtime sponge fan Marisa Dawson, a nurse, called the U.S. approval "great news" but said she believes the government dragged out the process.
The Orlando, Fla. woman said she, like Elaine, snapped up a hoard of Today Sponges when they went off the market, then used a French brand and finally got Allendale sponges from Canadian Web sites.
"If you're in a committed relationship, the STDs are not the worry. The pregnancy is," said Dawson, 43, who said she has never had an unplanned pregnancy.