U.S. women are waiting for contraceptive sponge
The promise of "Today" is slipping into "tomorrow," as the once-popular contraceptive sponge continues to be reviewed by the Food and Drug Administration (FDA).
All distribution is waiting to go, pending FDA inspection of the plant that will be used to manufacture the product, says Gene Detroyer, president and CEO of Allendale (NJ) Pharmaceuticals. Allendale Pharmaceuticals purchased rights to the popular over-the-counter device from American Home Products of Madison, NJ, in early 1999. (Contraceptive Technology Update reported on the company’s acquisition of the sponge in the May 1999 issue. )
The sponge was withdrawn from the market in 1995 when its former owners determined it was too costly to correct manufacturing problems at the factory where the contraceptive was made. Allendale moved the manufacturing to another site and began working with the FDA in acquiring approval to reintroduce the product.
According to Detroyer, the FDA will not go to the proposed plant, which manufactures other products, until it is assured that deficiencies that surfaced in March 2000 during an inspection for another company have been corrected. "It matters not at all that these deficiencies do not apply to the sponge," says Detroyer. "So, the timing is up to the agency."
FDA spokeswoman Susan Cruzan declined to comment on the status of the approval, other than to say that the information is under review. The FDA’s nonprescription drugs advisory committee reviewed the Today sponge’s labeling and other remarketing issues in July. All appropriate retail outlets have agreed to carry the Today sponge once Allendale Pharmaceuticals gets the green light from the FDA, says Detroyer.
Women in Canada have had access to a contraceptive sponge, Protectaid, since it was introduced as an over-the-counter method in 1996. The sponge contains three spermicides — nonoxynol-9, benzalkonium chloride, and sodium cholate — in a formulation of 0.125% w/w (weight in weight) of nonoxynol-9 and benzalkonium chloride, and 0.5% of sodium cholate.1 The Today sponge contains 1,000 mg of the spermicide nonoxynol-9.
Protectaid soon will have competition in Canada, as Allendale Pharmaceuticals has received approval for Canadian distribution of the Today sponge, confirms Detroyer.
The company that produces Protectaid, Pirri Pharma Canada Ltd., with offices in Quebec and Wiesbaden, Germany, has gained CE marking, which serves as a "passport" for sales in the countries that make up the European Union.
Distribution in the United Kingdom (U.K.) has just been announced by the company. According to Rudolf Simons, head of Pirri Pharma, the U.K. distribution will be handled by Sinclair Pharmaceuti-cals of Surrey, England. Spanish distribution, the second introduction in the European Union, will be handled by Euro Distribuciones Medico Sanitarias S.L. in Madrid, Spain.
The debut of Protectaid in the United Kingdom marks the reintroduction of the sponge in that country. While contraceptive sponges are not the first choice for contraception due to existence of more effective methods, they are useful in adjunctive birth control, says John Guillebaud, MA, FRCS(Ed), FRCOG, MFFP, professor of family planning and reproductive health at University College London and medical director of the Margaret Pyke Family Planning Centre, all in London.
The Today sponge offers a perfect use failure rate in the first year of use for parous women of 20%, with a typical use rate of 40%; in nulliparous women, perfect use rate is estimated at 9%, and typical use rate is 20%.2 Reported 12-month pregnancy rates for women, regardless of parity, using the Protectaid sponge are 23% for typical use.3
Protectaid might find a home in the United States, says Simons. "We are definitely planning to introduce Protectaid in the U.S., though we still have to go through the regulatory procedure. Obviously, we would like to make the product available not only as a contraceptive, but for the prevention of sexually transmitted diseases and HIV, which require clinical trials as well."
Allendale Pharmaceuticals is seeking similar distribution in the United Kingdom. According to Detroyer, approvals are complete, and the company expects to introduce the sponge in the United Kingdom. in the first quarter of 2001.
The road to FDA approval for any new device, such as the Protectaid sponge, will require clinical trials. Since the decision to remove the Today sponge was made by its then-manufacturer, and not the FDA, its regulatory approval status remained intact. Thus, Allendale Pharmaceutical was not required to run new clinical trials on the device.
References
1. Brady CS, Sauriol C, Colin P. In-vitro activity of F-5 gel used in the Protectaid contraceptive sponge against various Chlamydia trachomatis serotypes. Int Conf AIDS 1996; 11(2):16 (abstract no. We.A.511).
2. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York: Ardent Media; 1998.
3. Colin P, Creatsas G, Serfaty D, et al. Multinational, open phase II study of the efficacy, safety, and acceptability of the Protectaid contraceptive sponge. Presented at the annual meeting of the Society of Gynecologists and Obstetricians of Canada. Ottawa; June 1999.
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