Update: Today contraceptive sponge returns to U.S. drugstore shelves
Women who have been waiting for news of the Today contraceptive sponge’s re-emergence on U.S. market shelves can relax; the popular over-the-counter contraceptive should return to drugstore shelves this summer following the Food and Drug Administration’s (FDA’s) recent approval of the sponge’s manufacturing facility.
Allendale (NJ) Pharmaceuticals plans to begin U.S. production immediately, and it will begin retail distribution this summer, reports Gene Detroyer, Allendale Pharmaceuticals’ president and chief executive officer. Retail cost for the sponge should be about $2.50 to $3 each.
The sponge was not removed from the market by the FDA. Its former manufacturer, Whitehall-Robins Healthcare of New York City, ceased production when it determined it cost too much to correct problems caused by water quality issues at the old factory where the sponge was made. Allendale Pharmaceuticals acquired manufacturing and marketing rights to the sponge in 1999, and it has been working with the FDA since that time to have updated labeling and manufacturing approved for the over-the-counter contraceptive.
About 250 million sponges were sold between Today’s 1983 market debut and its 1995 removal from American drug store shelves. The device has been available in Canada since 2003; since its debut, more than 400,000 sponges have been sold through retail outlets and Internet sites.1
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The Today Sponge is circular in shape, 2 inches in diameter and three-quarters of an inch thick, with an attached loop. Made of polyurethane, it contains 1,000 mg of the spermicide nonoxynol-9 (N-9). It is moistened with tap water prior to use and inserted deep into the vagina. Removal is achieved by pulling the attached loop.
A single Today Sponge allows for as many acts of intercourse as desired within a 24-hour time frame without the need to change protection. According to the company’s product information, the Today sponge should not be left in place for more than 30 hours after insertion (which includes the six-hour waiting period after the last act of intercourse). It should not be used during menstruation; immediately after childbirth, miscarriage, or other termination of pregnancy; or by a woman who has ever been diagnosed with toxic shock syndrome, the company says. A physician should be consulted in such cases, the company advises. Women using the sponge who experience two or more of the warning signs or symptoms of toxic shock syndrome — including fever, vomiting, diarrhea, muscular pain, dizziness, or rash similar to sunburn — are advised to contact a physician immediately.
In the array of available contraceptive options, the sponge falls below the diaphragm in contraceptive effectiveness. In a 2003 review of available data,2 the sponge was found to be statistically significantly less effective in preventing overall pregnancy than was the diaphragm in the two trials that met analysts’ inclusion criteria, one performed in the United States3 and one in the United Kingdom.4
The 12-month cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge vs. 12.8 for the diaphragm in the U.S. trial, and 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Discontinuation rates at 12 months were higher with the sponge than with the diaphragm.2
Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two studies. In the U.S. trial, the 12-month cumulative life-table discontinuation rate for allergic-type reactions per 100 women were 4.0 for the sponge, vs. 0.7 for the diaphragm. The corresponding figures from the British trial were 0.9 and 0.0, respectively. Allergic-type complaints included dermatitis, erythema, and irritation, with vaginal itching as the chief discomfort-related complaint.2
While early research indicated that the N-9 contained in the sponge may reduce the risk of some sexually transmitted diseases (STDs),5,6 more recent investigations suggest that effect is unlikely.7,8 The FDA is making labeling changes for all vaginal contraceptives containing N-9 to help users understand that the use of such products can increase vaginal irritation, which may heighten the possibility of acquiring the AIDS virus and other STDs from infected partners. Women at risk for STDs should use a condom with the Today Sponge for maximum protection against STDs and pregnancy, advises the company.
Women like the sponge for its ease of use and appreciate that it’s female-controlled, Detroyer says. Users can choose when they want protection and when they don’t. Daily calls and e-mails from women confirm that there still is a great need for the contraceptive option, reports Detroyer.
"Women who cannot tolerate hormonal contraceptives or choose not to use them are particularly pleased by the return of the sponge," he states.
References
1. Johnson LA. Contraceptive sponge to return to market. The Washington Post, April 23, 2005. Accessed at: www.washingtonpost.com/wp-dyn/content/article/2005/04/22/AR2005042200605_pf.html.
2. Kuyoh MA, Toroitich-Ruto C, Grimes DA, et al. Sponge versus diaphragm for contraception: A Cochrane review. Contraception 2003; 67:15-18.
3. Edelman DA, McIntyre SL, Harper J. A comparative trial of the Today contraceptive sponge and diaphragm. Am J Obstet Gynecol 1984; 150:869-876.
4. Bounds W, Guillebaud J. Randomised comparison of the use-effectiveness and patient acceptability of the Collatex (Today) contraceptive sponge and the diaphragm. Br J Fam Plann 1984; 10:69-75.
5. Rosenberg MJ, Rojanapithayakorn W, Feldblum PJ, et al. Effect of the contraceptive sponge on chlamydial infection, gonorrhea, and candidiasis. A comparative clinical trial. JAMA 1987; 257:2.308-2,312.
6. Rosenberg MJ, Feldblum PJ, Rojanapithayakorn W, et al. The contraceptive sponge’s protection against Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis 1987; 14:147-152.
7. Roddy RE, Zekeng L, Ryan KA, et al. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N Engl J Med 1998; 339:504-510.
8. Roddy RE, Zekeng L, Ryan KA, et al. Effect of nonoxynol-9 gel on urogenital gonorrhea and chlamydial infection: A randomized controlled trial. JAMA 2002; 287:1,117-1,122.
Women who have been waiting for news of the Today contraceptive sponges re-emergence on U.S. market shelves can relax; the popular over-the-counter contraceptive should return to drugstore shelves this summer following the Food and Drug Administrations (FDAs) recent approval of the sponges manufacturing facility.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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