Time for Today sponge in Canada — will U.S. see vaginal contraceptive?
Time for Today sponge in Canada — will U.S. see vaginal contraceptive?
Company is seeking FDA approval for marketing in United States
Four years after its initial announcement to revive the Today contraceptive sponge, the company responsible for its rebirth finally has released the product in Canada and says it is pressing for Food and Drug (FDA) approval to market the device over the counter in the United States.
The sponge is available for sale over the Internet on two Canadian web sites, www.birthcontrol.com and www.feelbest.com, says Robert Staab, PhD, chairman and chief scientific officer of Allendale (NJ) Pharmaceuticals. At Contraceptive Technology Update press time, he predicted it would be on Canadian pharmacy shelves and other mass-merchandising outlets this month. The sponges are priced at the U.S. equivalent of about $2.90 each on the two web sites. While the sponge is not for sale in the United States, American women are ordering the device from the Canadian web sites.1
Women have awaited news of the sponge’s re-emergence; some 250 million sponges were sold between Today’s 1983 market debut and 1995 removal.2
The FDA did not remove the sponge from the market; 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.
Allendale Pharmaceuticals originally planned to reintroduce the sponge in the American market in fall of 1999. Tougher new FDA standards for manufacturing and record keeping resulted in repeated delays and a switch from a contract manufacturer in Mainland, PA, to OSG Norwich (NY) Pharmaceuticals.1
The contraceptive sponge still is under review, confirms Susan Cruzan, FDA spokeswoman. What is required to move the company’s request forward?
The New Drug Application (NDA) for the sponge remains active; however, Allendale Pharmaceuticals must submit two supplements for FDA approval. One supplement is for the product label, which has been submitted to the FDA for its review, says Staab. The second supplement is to change the manufacturing plant to the OSG Norwich site.
According to Staab, the company has product stability material ready for the FDA’s review, which is scheduled for this month. The FDA also may elect to perform a preapproval inspection for manufacturing compliance at the OSG Norwich site, which has an "excellent" compliance record, he reports.
Examine the sponge
The Today Sponge is circular in shape, two 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.
The sponge protects for up to 24 hours, no matter how many times intercourse occurs. 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 women who have ever been diagnosed with toxic shock syndrome. 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.
The advantages of the sponge are that it is simple to use and noninvasive, and it can be used intermittently with little advance planning.3 Unlike the diaphragm, the sponge can be used for more than one coital act within 24 hours without the insertion of additional spermicide, and it does not require fitting or a prescription from a health care provider.4
In the array of available contraceptive options, the sponge falls below the diaphragm in contraceptive effectiveness. In a recent review of available data, the sponge statistically was 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 States5 and one in the United Kingdom.6 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.4
Allergic 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 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. Allergic-type complaints included dermatitis, erythema, and irritation, with vaginal itching as the chief discomfort-related complaint.4
Alternate agent on tap?
While early research indicated that the N-9 contained in the sponge may reduce the risk of some sexually transmitted diseases (STDs),7,8 more recent research suggests that effect is unlikely.9,10 The FDA has proposed labeling changes for all vaginal contraceptives containing N-9 to help users understand that the use of such products can increase vaginal irritation, which actually may heighten the possibility of acquiring the AIDS virus and other STDs from infected partners.
The formulation for the current sponge is exactly the same as that was approved in the original NDA; Allendale Pharmaceuticals cannot change it, says Staab.
The company is looking at alternative spermicides/microbicides for the Sponge format, he says. To make such a change, the company would have to go through the full regulatory process to ensure the safety and efficacy of the product, which would be a "big project," Staab notes.
References
1. Associated Press. Sponge contraceptive on sale again. USA Today. March 4, 2003: Accessed at www.usatoday.com/news/health/2003-03-04-sponge-returns_x.htm.
2. Zernike K. Women gleeful at return of sponge contraceptive. New York Times; March 7, 2003. Accessed at www.nytimes.com/2003/03/07/health/07SPON.html.
3. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th revised ed. New York City: Ardent Media; 1998.
4. Kuyoh MA, Toroitich-Ruto C, Grimes DA, et al. Sponge versus diaphragm for contraception: A Cochrane review. Contraception 2003; 67:15-18.
5. Edelman DA, McIntyre SL, Harper J. A comparative trial of the Today contraceptive sponge and diaphragm. Am J Obstet Gynecol 1984; 150:869-876.
6. 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.
7. 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.
8. 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.
9. Roddy RE, Zekeng L, Ryan KA, Tamoufe U, 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.
10. 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.
Four years after its initial announcement to revive the Today contraceptive sponge, the company responsible for its rebirth finally has released the product in Canada and says it is pressing for Food and Drug (FDA) approval to market the device over the counter in the United States.Subscribe Now for Access
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