The previous manufacturer, American Home Products, stopped making the Today Sponge in 1994, along with other products, due to complications with its production facilities. The move to halt production was an economic decision, unrelated to safety of the Sponge.

Allendale Pharmaceuticals, a New Jersey-based consumer healthcare products company, bought the rights to the Today Sponge in 1998 and has been navigating the FDA approval process ever since. Last week's announcement means women in the United States once again will have access to this effective, hormone-free, contraceptive choice, the company says.

Benefits of the Sponge

Despite its absence from store shelves for the past decade, 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."

Benefits of the Today Sponge include the following, according to Allendale:

As Effective as Condom

Clinical studies on more than 1,800 women have shown the Today Sponge is 89-91% effective at preventing pregnancy when used as directed -- an effectiveness rate similar to other female over-the-counter contraceptives.

The clinical trials were conducted at 26 sites in nine countries including the United States. During typical use, women using the Today Sponge can expect birth control effectiveness that is comparable to the male condom.

"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 Pharmaceuticals.

These results reflect those who used the product perfectly as well as those who did not use the Sponge correctly or did not use the Sponge with every act of intercourse. It is important to understand the effectiveness rate is based on one year of Sponge use and does not mean that the product fails about every tenth 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 company explains.

Does Not Protect Against STDs

The Today Sponge was the first successful product to incorporate a spermicide into a barrier contraceptive, notes Allendale. The Today Sponge is a reservoir for one gram of Nonoxynol-9, the most widely used spermicide in the world.

The advantages of the Today Sponge are that it works to prevent pregnancy in three ways:

Other advantages of the Today Sponge include the fact that it contains no hormones and it allows women to take control of contraception, the company points out. Once inserted, the Today Sponge is effective immediately and remains effective for 24 hours without the need for applications of spermicidal creams, foams or gels. A single Today Sponge allows for as many acts of intercourse as desired within a 24-hour timeframe without the need to change protection.

For maximum protection against pregnancy, the Today Sponge must be left in place for at least six hours after the last act of intercourse. It should not remain inserted for more than 30 hours. The Today Sponge does not protect against sexually transmitted diseases. Those at risk for STDs should use a condom in conjunction with the Today Sponge for maximum protection against STDs and pregnancy.