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Summer Comeback Seen for Contraceptive Sponge


 

More than a decade after it was taken off the market because of manufacturing issues, the contraceptive sponge has been cleared by the Food and Drug Administration and is expected to be available this summer.

The Today Sponge, which is made of polyurethane foam and contains a 1-g reservoir of nonoxynol-9, will be available over the counter this summer, according to Allendale Pharmaceuticals Inc., the N.J.-based company that bought the rights to the product in 1998. It is the same device taken off the market in 1994, when safety issues were raised with the facilities where the sponge was manufactured.

One sponge, which provides a barrier between the cervix and sperm, continually releases 125ndash;150 mg of nonoxynol-9 into the vagina and can be used for 24 hours, the company said. The polyurethane foam “traps and absorbs semen” before the sperm are able to enter the cervix. It must be left in place for at least 6 hours after the last act of intercourse, and it does not protect against sexually transmitted diseases, the company said.

In multicenter clinical trials of more than 1,800 women conducted in the United States and eight other countries before the device was pulled from the market, the sponge was 89% effective in preventing pregnancies during 1 year among 939 parous women studied and 91% effective among 915 nulliparous women studied, when used properly for every act of intercourse, according to the company. When used improperly and inconsistently, the effectiveness rate ranged from 84%ndash;87%, the company said.

Use of the Today Sponge is contraindicated in individuals who are allergic or sensitive to nonoxynol-9. Typical symptoms can include vaginal burning, itching, redness, rash, and irritation. In the U.S. portion of the clinical study, 4% of women discontinued use of the sponge due to allergic symptoms. Worldwide, this figure was 2.1%. If the user or her partner is allergic to sulfa drugs, he or she should consult a physician before using the sponge.

The sponge is contraindicated for use during menstruation. Some cases of nonmenstrual toxic shock syndrome have been reported in women using barrier contraceptives, including Today Sponge, the diaphragm, and the cervical cap.

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