A Medical Device Daily
Allendale Pharmaceuticals (Allendale, New Jersey) last week reported that it has won re-approval from the FDA for the Today Sponge, which it termed “once the most popular over-the-counter female contraceptive.”
The Today Sponge was available in the U.S. from 1983 to 1994 and more than 250 million Sponges were sold by its previous manufacturer, American Home Products (AHP; Madison, New Jersey). AHP stopped manufacturing the Today Sponge in 1994, along with other products, “due to complications with its production facilities,” Allendale said in a statement. It emphasized that the move by AHP “was an economic decision, unrelated to safety of the Sponge.”
Allendale said it plans to begin production immediately for the U.S. market and will launch national distribution this summer.
A consumer healthcare products company, Allendale bought the rights to the Today Sponge in 1998, “navigating,” it said, “the FDA approval process since then.”
The company reported studies on more than 1,800 women, showing the sponge to be effective for preventing pregnancy 89% to 91% of the time “when used as directed,” the company calling that an effectiveness rate similar to other female over-the-counter contraceptives.
The company’s clinical trials were conducted in nine countries, including the U.S.
“Based on clinical studies conducted on women using the Today Sponge, an estimated 230,000 acts of intercourse resulted in 179 pregnancies,” said Dr. Robert Staab, chairman and chief scientific officer of Allendale. He noted that the rate “is based on one year of Sponge use and does not mean that the product fails about every 10th use. During the year of perfect and imperfect use by couples in these FDA-reviewed clinical studies, one pregnancy resulted from about 1,000 acts of intercourse.”
The device’s advantages, the company says, are that it contains no hormones, is available over the counter, is disposable, and requires no foams or gels.
Allendale said the Today Sponge was the first successful product to incorporate a spermicide into a barrier contraceptive. The device provides a reservoir for one gram of Nonoxynol-9, a widely used spermicide, and the device’s polyurethane foam helps to trap and absorb semen.
Despite its absence from the U.S. market, Allendale said that the Today Sponge enjoys strong customer demand.
“Daily calls and e-mails from women confirm that there is still a great need for the Today Sponge,” said Gene Detroyer, president and CEO of Allendale. “Women who cannot tolerate hormonal contraceptives, or choose not to use them, are particularly pleased by the return of the Sponge.”
Re-entry to the U.S. market has been anticipated since the product’s approval and market release in Canada in 2003. And the company has reported “heavy activity” on its Today Sponge hotline and its web site.
Allendale was established in 1997 by Dr. Robert Staab and Gene Detroyer. It said it would expand the Today brand over the next year with the release of a line of personal lubricants for women as well as other reproductive health products.