FDA Allows U.S. Sale of Today Sponge 10 Years After Withdrawing Contraceptive

Main Category: Women's Health / Gynecology
Article Date: 26 Apr 2005 - 9:00 PDT

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The FDA on Friday announced it has granted regulatory approval for the contraceptive Today Sponge, which was one of the best-selling nonprescription female contraceptives in the United States before it was taken off the market 10 years ago, the... AP/Yahoo! News reports (Johnson, AP/Yahoo! News, 4/22). The device, which is constructed of soft polyurethane foam and is inserted into the vagina for up to 24 hours, provides barrier protection and spermicide to prevent pregnancy. The device, which contains the spermicide nonoxynol-9, is 89% to 91% effective in preventing pregnancy but does not protect against sexually transmitted diseases (Maugh, Los Angeles Times, 4/23). The sponge was introduced in 1983, but sales of the product were discontinued in 1995 because its manufacturer, Whitehall-Robbins -- now known as Wyeth Consumer Health Care -- did not want to invest in the equipment upgrades necessary for maintaining FDA approval. However, Allendale Pharmaceuticals in 2000 purchased the manufacturing rights to the sponge and had been working to meet FDA requirements ever since. New Jersey-based OSG Norwich Pharmaceuticals in March 2003 received a three-year, renewable contract from Allendale to be the sole manufacturer of the Today Sponge, which had sales of approximately 250 million between 1983 and 1995 (Kaiser Daily Reproductive Health Report, 3/5/03).

Details
The sponge is scheduled to be available to U.S. women through Allendale's Web site by June and in U.S. stores by August, USA Today reports. The sponges will be sold in packs of three and sell for between $2.50 and $3 per sponge, according to USA Today (Weise, USA Today, 4/25). Allendale, which is planning an advertising campaign for the sponge, says it expects to sell about 15 million of the sponges in the first year of sales, the New York Daily News reports (Katz, New York Daily News, 4/23). "The number of calls and e-mails from women all these years confirms that there's still a great need. Maybe even greater than there was the first time around because there's so much more sensitivity about using hormones -- especially for a long period of time," Allendale CEO Gene Detroyer, who also is a co-founder of the company, said (Miller Rubin, Chicago Tribune, 4/23). The sponge has been available in Canada for the past two years, according to USA Today (USA Today, 4/25).

Today Sponge

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