The sponge is back
Sorry had to. One of the best Seinfeld episodes ever!
The Food and Drug Administration on Friday approved U.S. sales of the sponge, which was the favorite nonprescription birth control product among women when it was withdrawn from the market in 1995.
The withdrawal sparked a run of fiercely loyal fans hoarding every sponge they could find, as well as a hilarious sendoff on the sitcom 'Seinfeld,' in which character Elaine Benes coined the term 'spongeworthy.' Like many real women, Elaine scoured pharmacies until she found a case of her favorite birth control. She then stretched her supply by setting 'spongeworthy' standards for prospective lovers.
Now the polyurethane sponges, which manufacturer Allendale Pharmaceuticals has sold in Canada and over the Internet since March 2003, will be available shortly in the U.S. through a company Web site.
Soon after that, the product will be available at retail drug chains, followed by supermarkets and mass marketers such as Wal-Mart, Allendale said.
Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth of Madison. Wyeth, then called American Home Products, had stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned.
'I'm overwhelmed,' Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals, told The Associated Press in an exclusive interview. 'I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women.'
FDA spokeswoman Susan Cruzan confirmed the approval.
'They can re-enter the U.S. market,' she said. 'The product was found to be safe and effective.'
The Today Sponge prevents pregnancy by covering the cervix and releasing spermicide from inside the soft, concave device. Roughly 250 million of the sponges were sold from 1983 to 1995.
While it was less effective than several other methods and does not protect against sexually transmitted diseases, the sponge achieved a wide following among women who saw advantages from spontaneity to wide availability.
The sponge can be inserted well before sex and kept handy in a purse. It isn't messy like contraceptive creams, doesn't limit sensitivity like condoms, is easy to insert and remove, doesn't require a prescription or professional fitting and, unlike oral contraceptives, doesn't put hormones in the body.
However, the sponge is far less effective 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.
'It's always a good thing when women have more choices about which contraceptive to use, because then there is a greater chance that they can find a method they can use correctly and consistently,' said James Trussell, director of Princeton University's Office of Population Research.
'However, this is a particularly poor option for women who have already had a child because effectiveness is so low among such women,' Trussell added. 'We don't know why that is.'
Trussell said research he published last summer in the medical journal Contraception found a one-year pregnancy rate of 26 percent for users of the Today Sponge who have had a baby. Allendale Pharmaceuticals said the pregnancy rate is the same whether the woman has had a baby or not.
In Canada, where the original Today Sponge was only on the market about 18 months, more than 400,000 sponges have been sold through retail outlets and Internet sites -- without any advertising -- since they were approved for sale there two years ago.
Detroyer 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. That's the current production limit of the company's factory in Norwich, N.Y., but the company has plans to double that.
Detroyer and Allendale chairman Robert J. Staab initially hoped to get Today Sponge back on the U.S. market shortly after getting rights to the product in December 1998. Partly because the product is much more difficult to manufacture than a pill or liquid, they ran into repeated plays and setbacks as they sought FDA approval.
Two years ago, FDA allowed the company to make the product in its U.S. factory for sales in Canada.
The Food and Drug Administration on Friday approved U.S. sales of the sponge, which was the favorite nonprescription birth control product among women when it was withdrawn from the market in 1995.
The withdrawal sparked a run of fiercely loyal fans hoarding every sponge they could find, as well as a hilarious sendoff on the sitcom 'Seinfeld,' in which character Elaine Benes coined the term 'spongeworthy.' Like many real women, Elaine scoured pharmacies until she found a case of her favorite birth control. She then stretched her supply by setting 'spongeworthy' standards for prospective lovers.
Now the polyurethane sponges, which manufacturer Allendale Pharmaceuticals has sold in Canada and over the Internet since March 2003, will be available shortly in the U.S. through a company Web site.
Soon after that, the product will be available at retail drug chains, followed by supermarkets and mass marketers such as Wal-Mart, Allendale said.
Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth of Madison. Wyeth, then called American Home Products, had stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned.
'I'm overwhelmed,' Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals, told The Associated Press in an exclusive interview. 'I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women.'
FDA spokeswoman Susan Cruzan confirmed the approval.
'They can re-enter the U.S. market,' she said. 'The product was found to be safe and effective.'
The Today Sponge prevents pregnancy by covering the cervix and releasing spermicide from inside the soft, concave device. Roughly 250 million of the sponges were sold from 1983 to 1995.
While it was less effective than several other methods and does not protect against sexually transmitted diseases, the sponge achieved a wide following among women who saw advantages from spontaneity to wide availability.
The sponge can be inserted well before sex and kept handy in a purse. It isn't messy like contraceptive creams, doesn't limit sensitivity like condoms, is easy to insert and remove, doesn't require a prescription or professional fitting and, unlike oral contraceptives, doesn't put hormones in the body.
However, the sponge is far less effective 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.
'It's always a good thing when women have more choices about which contraceptive to use, because then there is a greater chance that they can find a method they can use correctly and consistently,' said James Trussell, director of Princeton University's Office of Population Research.
'However, this is a particularly poor option for women who have already had a child because effectiveness is so low among such women,' Trussell added. 'We don't know why that is.'
Trussell said research he published last summer in the medical journal Contraception found a one-year pregnancy rate of 26 percent for users of the Today Sponge who have had a baby. Allendale Pharmaceuticals said the pregnancy rate is the same whether the woman has had a baby or not.
In Canada, where the original Today Sponge was only on the market about 18 months, more than 400,000 sponges have been sold through retail outlets and Internet sites -- without any advertising -- since they were approved for sale there two years ago.
Detroyer 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. That's the current production limit of the company's factory in Norwich, N.Y., but the company has plans to double that.
Detroyer and Allendale chairman Robert J. Staab initially hoped to get Today Sponge back on the U.S. market shortly after getting rights to the product in December 1998. Partly because the product is much more difficult to manufacture than a pill or liquid, they ran into repeated plays and setbacks as they sought FDA approval.
Two years ago, FDA allowed the company to make the product in its U.S. factory for sales in Canada.
