Manufacturer Pushes for Sponge Return to U.S.

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Gene Detroyer

(WOMENSENEWS)–Gene Detroyer remains hopeful that the contraceptive sponge will return to the U.S. market in a matter of months.

The president and chief executive officer of the sponge’s present owner, Allendale Pharmaceuticals, Inc., Detroyer says he expects to submit the last bits of paperwork to the Food and Drug Administration this month; FDA approval often takes four to six months.

The company is now awaiting several authorizations from the FDA, including that of new package labeling with up-to-date information on effectiveness rates and potential health risks including toxic shock syndrome.

Detroyer says he receives e-mails every day from women telling him the contraceptive methods available are not the right options for them. “In particular, women who have a family history of breast cancer who do not want to introduce unnecessary hormones into their systems,” he says.

The over-the-counter birth control product that contains the spermicide Nonoxynol-9 has been on the verge of reentering the U.S. market for nine years. During that time–as the rights to produce the small, cushion-shaped pieces of polyurethane foam changed ownership and factory sites several times–new and more effective family planning options have been approved, including the contraceptive patch, the vaginal ring and safe and effective intrauterine devices, or IUDs.

Nonetheless, Detroyer still thinks the non-hormonal, over-the-counter sponge has a small but important U.S. birth-control-niche to fill.

Allendale has been exporting Today Sponges to Canada for about six months, where they are selling in many drugstore chains, including Wal-Mart. In just eight months, Allendale met their first-year sales goals in Canada, he says, with sponges moving off the shelves at a rate of about 40,000 per month.

Alternative to Hormonal Birth Control

If Allendale does succeed in ushering the contraceptive sponge back to market later this year it would likely find its niche among women who cannot or prefer not to use a hormonal birth control method. Older women willing to accept the method’s higher risks of unintended pregnancy or who prefer not to use hormones, are two such groups; younger women who favor the convenience of over-the-counter methods are another.

Detroyer says he still feels manufacturing the sponge is worth the effort because it provides such women another birth control option.

“Maybe that’s why we’re doing it and a big company isn’t,” says Detroyer, of his five-person Allendale, N.J., operation. “This stuff doesn’t make a whole lot of difference to big companies.”

The Today Sponge was first released in 1983 and about 15 million were sold annually until 1993, when the factory where it was manufactured failed to pass inspection. In 1995, the sponge was pulled from the market by then-owner, American Home Products Corporation, after high levels of bacteria were found in the plant’s waters. Rather than investing in renovating the facility or footing the bill for a new production line elsewhere, the Madison, N.J., based corporation stopped production. American Home Products Corporation changed its name to Wyeth in 2002.

In December 1998, Allendale Pharmaceuticals purchased the rights to manufacture and market the Today Sponge. “It appeared to be a good business opportunity,” says Detroyer. The sponge was a “unique product” with an approved new drug application that could be brought back to market with relative ease, Detroyer believed. “It turned out we were a bit wrong on the ‘relative ease’ part,” Detroyer says, “but no matter, it is still an excellent business opportunity.”

If the Today Sponge is allowed back on to the U.S. market, Allendale will be the sole U.S. company manufacturing it.

Over-the-Counter, One-Size-Fits-All

Despite its factory troubles, the sponge itself never lost FDA approval.

“When the sponge was available, some women found that it fit neatly and conveniently into their lifestyles, says Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America. For example, a woman who wants to get pregnant in the near future may not want to use a hormonal method, Cullins explains. Other appealing features of the sponge are that it can be purchased over-the-counter without a prescription and its one-size-fits-all construction means it doesn’t have to be fitted. It’s less messy than other barrier methods such as contraceptive foams and is disposable.

When inserted into the vagina, the sponge can protect against pregnancy in several ways: by releasing spermicide, by physically blocking the sperm’s access to the cervix and by absorbing sperm into the foam. The sponge can be inserted up to 24 hours before having intercourse and a partner may be unaware of its use. When re-released, sponges will still be fairly inexpensive, probably between $2 to $2.50 each, says Detroyer.

The sponge does have some important drawbacks. In addition to not providing protection against sexually transmitted diseases, it is also less effective than many other birth-control methods. The current packaging cites a pregnancy protection rate of about 86 percent, well below that of birth control pills and many other contraceptive options, which can boast protection rates of over 99 percent. The sponge’s protection rates also go down if the woman using the sponge has had a vaginal delivery; these women typically have larger cervical openings, making it less likely that the sponge covers the entire cervix.

“If the sponge provides a contraceptive option for a woman who isn’t currently using any form of birth control or who is not happy with the methods presently available, that would be a benefit,” says Dr. Mitchell Creinin, director of family planning and family planning research at the University of Pittsburgh School of Medicine.

Planned Parenthood’s Cullins adds, “the best birth control methods are those that meet women’s needs and those needs may change throughout a woman’s life.”

Concerns Voiced Over Safety

At least one group, Associated Pharmacologists and Toxicologists, have voiced concern over the device’s safety, mainly from the risk of toxic shock syndrome and the use of Nonoxynol-9, a spermicide that is also used in other pregnancy prevention methods. The group, made up of a handful of reproductive toxicology experts based in Washington, D.C., filed a Citizen’s Petition–comments filed by the public, usually requesting changes in regulations–with the FDA requesting that approval of the sponge be withdrawn.

The FDA denied the group’s petition in part because the Today Sponge’s packaging now contains a warning about toxic shock, a rare, but potentially life-threatening bacterial infection that was associated with tampon use in the 1980s. Toxic shock can potentially be caused by any substance or device that causes vaginal irritation.

Recent Nonoxynol-9 research indicates that the spermicide is considered safe for contraception in women at low risk for sexually transmitted infections, says Cullins. However, in January 2004, SSL International, the United Kingdom-based maker of Durex condoms, stopped producing condoms with Nonoxynol-9, citing studies that showed it may increase HIV transmission among women by damaging the cell lining of the vagina and cervix.

Men or women who use Nonoxynol-9 for multiple episodes of intercourse in a day and who are exposed to a sexually transmitted infection could be at increased risk for acquiring sexually transmitted diseases, according to the World Health Organization.

“We agree with the World Health Organization on Nonoxynol-9 and don’t think it should be used even in the Sponge by high-risk populations,” Detroyer says. “But they say that under normal circumstances and for contraception N-9 is perfectly safe.”

Allendale is in the process of updating its license for selling the Sponge in the United Kingdom and subsequently plans to apply for approval to sell in other European Union countries.

Kathleen Nelson is a freelancer who writes about health and medicine.

For more information:

Today Sponge:
http://www.todaysponge.com

Planned Parenthood Federation of America–Ask Dr. Cullins
Q: I hear the sponge is back! Who’s it best for?
http://www.plannedparenthood.org/drcullins/030306_sponge.html


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