FDA Application Submitted For Softcup OTC Fertility Aid
La Jolla, CA - Women's health company Instead Inc. filed a 510(k) application with the U.S. Food and Drug Administration (FDA) this week to obtain clearance to market its Instead Softcup product as an over-the-counter (OTC) fertility aid. A decision from the FDA is expected within 90 days.
The move to seek new claims on the Softcup, currently marketed as a feminine hygiene product, was stimulated by an underground movement of Softcup users. These women were employing the product as an internal device to hold semen close to the cervix. Instead vice president and general manager, Teri Hirschfeld, said the trend was first discovered in letters from users and on the company's online message boards.
"These users, who represent a portion of the one in ten people of reproductive age affected by infertility, were seeking a simple and affordable option before going to more extreme measures," Hirschfeld said. "They had learned, either from each other or online, that the Softcup could be inserted immediately after intercourse to promote conception, and had the amazing success stories to prove it."
Potentially an OTC device for those trying to conceive (TTC), the Softcup is used as a reservoir to keep sperm close to the cervix. It may aid conception by helping maintain the maximum concentration of semen in the vicinity of the cervical opening. The Softcup must be inserted after sex while semen is still present near the cervix, or with sperm directly deposited in the cup itself, to promote conception.
"Beyond those experiencing infertility, we believe many of the more than three million women in the U.S. deciding to have babies every year will be interested in using the Softcup as an easily affordable and readily available way to potentially help advance the conception process."
Following the anticipated FDA clearance, Hirschfeld said the Instead Softcup will be sold with the new indication for fertility on the package at its current points of sale.
"The fertility claim represents an exciting expansion in the innovative applications of the disposable Instead Softcup, which has been on the market as a feminine hygiene product since 1997, and is the only menstrual protection product that can be worn during a woman's period for clean sex," Hirschfeld added.
Instead Softcups are currently sold at retail outlets nationwide, including Target, Walgreens, CVS, Wal-Mart, Rite-Aid, Kroger and Fred Meyer, and online at www.drugstore.com. A package of six retails for a suggested $3.49, a package of 14 for $7.49 and a package of 24 for $10.49.
Instead also recently announced that its candidate microbicide Amphora, which was cleared as a personal lubricant by the FDA in late 2004, will be used in a forthcoming clinical trial. A microbicide is a substance a woman can insert vaginally prior to intercourse to protect herself from infection by sexually transmitted diseases. Amphora was selected by the U.S. Centers for Disease Control and Prevention, the United States Agency for International Development, Contraceptive Research and Development, and the University of North Carolina at Chapel Hill for a formative research study in Madagascar to test its acceptance by urban women at high risk for sexually transmitted infections.
SOURCE: Instead, Inc.