The Today Sponge Coming (Back) Soon
July 13, 2001 (Washington) -- Is the Today sponge worthy of a comeback? Indeed, the female contraceptive made famous by Seinfeld'sElaine may be available again in the U.S -- and soon.
Yes, you've heard that before, but this time, it appears closer than ever and could be available in as little as 90 days, the manufacturer tells WebMD.
But if this proves to be another false alarm, women in search of a contraceptive other than the birth control pill do have some options, including a product that is very similar to the sponge.
After a meeting with the FDA a few weeks ago, Allendale Pharmaceuticals, which has been trying to bring the Today sponge back to the market since it was withdrawn, is confident the agency will allow it on the market by the end of the year.
Distribution in Canada could begin in the next three months, and U.S. distribution could begin by the end of the year, says Allendale CEO Gene Detroyer.
The Today sponge, which was previously produced by American Home Products, was withdrawn in 1995 due to production problems at the manufacturing plant. The recall had nothing to do with the safety of the sponge itself.
"Basically, everything is ready to go," Detroyer says. But the company still has to satisfy the FDA's concerns about some technical manufacturing details. "We won't know exactly until they give us some guidance," he says.
In the meantime, women have several alternatives. Protectaid, a product that is very similar to the sponge, is available in Canada and can be ordered over the Internet.
Protectaid can be used for only 12 hours, however, whereas the Today sponge can be left in place for 30 hours. Another difference is that Protectaid has never been through U.S. clinical trials like the sponge has, so "its effectiveness is not really known," Detroyer says.
This is an important point, because the two products work by different mechanisms. The Today sponge prevents pregnancy by delivering the sperm-killing compound nonoxynol-9 around the cervix. Protectaid, in contrast, uses nonoxynol-9 plus two other spermicides, benzalkonium chloride and sodium cholate.
The Today Sponge Coming (Back) Soon
July 13, 2001 (Washington) -- Is the Today sponge worthy of a comeback? Indeed, the female contraceptive made famous by Seinfeld'sElaine may be available again in the U.S -- and soon.
Yes, you've heard that before, but this time, it appears closer than ever and could be available in as little as 90 days, the manufacturer tells WebMD.
But if this proves to be another false alarm, women in search of a contraceptive other than the birth control pill do have some options, including a product that is very similar to the sponge.
After a meeting with the FDA a few weeks ago, Allendale Pharmaceuticals, which has been trying to bring the Today sponge back to the market since it was withdrawn, is confident the agency will allow it on the market by the end of the year.
Distribution in Canada could begin in the next three months, and U.S. distribution could begin by the end of the year, says Allendale CEO Gene Detroyer.
The Today sponge, which was previously produced by American Home Products, was withdrawn in 1995 due to production problems at the manufacturing plant. The recall had nothing to do with the safety of the sponge itself.
"Basically, everything is ready to go," Detroyer says. But the company still has to satisfy the FDA's concerns about some technical manufacturing details. "We won't know exactly until they give us some guidance," he says.
In the meantime, women have several alternatives. Protectaid, a product that is very similar to the sponge, is available in Canada and can be ordered over the Internet.
Protectaid can be used for only 12 hours, however, whereas the Today sponge can be left in place for 30 hours. Another difference is that Protectaid has never been through U.S. clinical trials like the sponge has, so "its effectiveness is not really known," Detroyer says.
This is an important point, because the two products work by different mechanisms. The Today sponge prevents pregnancy by delivering the sperm-killing compound nonoxynol-9 around the cervix. Protectaid, in contrast, uses nonoxynol-9 plus two other spermicides, benzalkonium chloride and sodium cholate.
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