By Liz White, UT staffAllendale, New Jersey-A popular polyurethane foam contraceptive device is once again available over the counter in the US, after an 11-year gap. A problem in its plant caused the previous manufacturer to halt production, but the device has now regained regulatory approval and women are apparently clamouring for supplies of the hormone-free family planning option, according to its manufacturer. Allendale Pharmaceuticals is marketing the Today Sponge-which it claims was “once the most popular over-the-counter female contraceptive”- following re-approval for marketing from the US regulatory body the Food and Drug Administration. The firm plans to start US production immediately, and said it will begin national distribution in summer 2005. Between 1983 and 1994, more than 250 million of these devices were sold, Allendale claims. American Home Products, which previously made the sponge, stopped production in 1994, “due to complications with its facilities,” Allendale said. The move was “an economic decision, unrelated to safety of the Sponge,” the firm added. New Jersey-based Allendale Pharmaceuticals, active in consumer healthcare products, bought the rights to the Today Sponge in 1998 and “has been navigating the FDA approval process ever since,” the firm’s statement said. Now women in the US “will once again have access to this effective, hormone-free, contraceptive choice,” Allendale added. Demand for the device is still high, the firm claims. “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 Pharmaceuticals. “Women who cannot tolerate hormonal contraceptives or choose not to use them are particularly pleased by the return of the Sponge,” Detroyer added. Dr Anne Davis, Assistant Professor of Clinical Obstetrics and Gynecology at Columbia University said in the Allendale statement, “As a practitioner, I can tell you that many women are looking forward to the return of the Sponge. Women need different contraceptive methods at different points in their lives.” Davis added that women say the sponge is “easy-to-use, convenient, and safe.” Allendale said that clinical studies on more than 1800 women show a pregnancy prevention rate for the sponge of 89-91 percent when used as directed-a rate similar to other female over-the-counter contraceptives. “
Breaking news and in-depth coverage of essential topics delivered straight to your inbox.
Breaking news and in-depth coverage of essential topics delivered straight to your inbox.View All Newsletters