Revival of the Today sponge: Vaginal contraceptive returns

New pharmaceutical company aims for fall reintroduction

This fall, American women may see a familiar package on drugstore contraceptive shelves: the Today sponge. A New Jersey company has acquired the rights to manufacture and market the sponge, which was removed from the market five years ago by its former maker. The announcement by Allendale (NJ) Pharmaceuticals was met with enthusiasm by women’s health advocates, who had decried New York City-based Whitehall-Robins Healthcare’s 1995 decision to withdraw the sponge from the market. The company had determined it cost too much to correct manufacturing problems caused by water quality issues at the old factory where the sponge was made.

"ARHP advocates for the availability of as many safe, effective methods of contraception as possible, and we are pleased that another important option will be returning to American women," says Felicia Stewart, MD, director of reproductive health programs at Kaiser Family Founda tion in Menlo Park, CA, and a member of the Washington, DC-based Association of Reproductive Health Professionals (ARHP).

The sponge was used by a group of women who wanted a disposable barrier device at a reasonable cost, says David Archer, MD, professor of OB/GYN at the Eastern Virginia Medical School and Jones Institute of Reproductive Medicine in Norfolk, VA. The withdrawal of the Today sponge caused this group of women to use condoms or local spermicides instead.

"It is apparent that a physical barrier provides the consumer with a more secure feeling in terms of a product that has a spermicidal property," observes Archer, who has conducted research of various contraceptive methods.

New company, same sponge

Newly-formed Allendale Pharmaceuticals intends to move swiftly to get the Today sponge on the market, say its founders, Gene Detroyer and Robert Staab, PhD. The Today sponge is still recognized by the Food and Drug Administration (FDA) as a safe and effective product, notes Staab, the company’s chairman and chief scientific officer. Its New Drug Application is still active, so no further clinical trials are required to prove the sponge’s safety and efficacy.

The company is moving the manufacturing facilities to a plant in Mainland, PA, that has an established safety record with the FDA, says Staab. Once equipment is in place, Allendale will begin manufacturing a test product that will be examined by the FDA. If the product and facility pass the test, Allendale hopes to begin mass manufacturing, with possible delivery to drugstores and other vendors in the fall, he says.

In buying the Today sponge from American Home Products of Madison, NJ, Whitehall-Robins’ parent company, Allendale Pharmaceuticals, acquired the worldwide rights to the Today name and packaging. Such built-in name recognition is a valuable plus for Allendale’s first product, says Detroyer.

If acceptable to the FDA, Allendale plans only minor changes for the sponge’s packaging. The result will be the reappearance of a product already familiar to many American women. To gauge consumer interest in the re-emergence of the Today sponge, Allendale posted questions on the Web site www.birthcontrol.com. (Birthcontrol.com is one of several sites offering access to birth control products. For details on such sites, see Contraceptive Tech nol ogy Update, September 1998, p. 120.) More than 200 e-mails — all positive — have been received, reports Detroyer.

While the Today sponge offers convenient, accessible birth control, it is important to frame all family planning choices in light of their effectiveness. The sponge ranks behind both male and female condoms in typical- and perfect-use scenarios. (See comparison of typical- and perfect-use rates for over-the-counter contraceptives, including the sponge, below.)

      Percentage of Women Experiencing an Unintended Pregnancy During First Year of Use

      Method
      Typical Use
      Perfect Use
      Spermicides
      26
      6

      Sponge
      Parous women
      40
      20
      Nulliparous women
      20
      9

      Condom
      Female (Reality)
      21
      5
      Male
      14
      3

      Source: Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th edition. New York City: Ardent Media; 1998.
      __________________________________________________

How will the sponge affect women and their health care providers? asks Anita Nelson, MD, associate professor of obstetrics and gynecology at the University of California at Los Angeles (UCLA) and medical director of the Women’s Health Care Clinic at the Harbor-UCLA Medical Center in Torrance, CA. "If women who are having unprotected intercourse now suddenly start using the sponge, it will have made an important contribution. If, however, women are wooed away from using oral contraceptives, depot medroxy progesterone acetate, or Norplant on the basis that the sponge is more natural’ or safer’ than hormonal methods, we will have lost ground."

Allendale Pharmaceuticals plans to follow the sponge’s re-emergence with other women’s health care products. Staab, a board-certified toxicologist, holds patents to several products, including a vaginal film.

The sponge purchase also included the acquisition of a personal lubricant and a condom. While Allendale does not intend to move into the condom market, it does intend to examine the lubricant as a possible addition to its product line.

The Today sponge will maintain use of its original active spermicide, nonoxynol-9, but Allendale Pharmaceuticals will examine use of the sponge as a "carrier" for other ingredients, such as other spermicidal agents, Staab says. The company also may license the sponge design to other pharmaceutical companies for use in prescription-only applications, Detroyer adds.

Allendale Pharmaceuticals plans to set up a Web site, www.todaysponge.com, as well as a toll-free hotline, to answer consumer questions about the sponge. Robert Hatcher, MD, MPH, professor of OB/GYN at Emory University in Atlanta and chairman of the CTU editorial advisory board, says the hotline will be extremely helpful to women who may have difficulty removing the device, a fairly common problem in the past.