NEW YORK (CNNfn) - The Today Sponge contraceptive, memorialized in an episode of the "Seinfeld" sitcom when it was pulled from the market in 1995, could return to pharmacy shelves next year, the manufacturer said Wednesday.|
"What we have to do is get the plant inspected," said Gene Detroyer, co-founder and CEO of Allendale Pharmaceuticals, which bought the rights to the sponge -- including the name and the manufacturing equipment -- last March.
The inspection by the federal Food and Drug Administration should take place in the next 30-to-60 days, Detroyer said Wednesday in an interview on the CNNfn "Market Call" program.
He did not give a time frame for getting the product back on the market.
Useful alternative for some
While the sponge was never a market leader, it sold more than 250 million units while it was available from 1983 to 1995 and was viewed as a valuable alternative for certain users.
A single sponge could provide 24 hours of protection against unwanted pregnancy, through repeated sexual encounters. The sponge functioned both as a barrier and as a carrier of the spermicide nonoxynol-9.
The biggest drawback to the product was a relatively high failure rate, said James Trussell of Princeton University, an expert in reproductive health. "It was not very effective, especially among women who already have given birth to a child," Trussell said.
A 1998 survey by Trussell and others found failure rates of 20 percent among women who already had had a child and 9 percent among those who had not, for women who used the device correctly and consistently for a full year, compared with a failure rate of less than 1 percent for women using birth-control pills.
"That doesn't mean it's not an important option," Trussell added. "Not every method fits every woman. Some women do like it."
While there were never any serious legal challenges to the sponge's safety or effectiveness, the manufacturer, a predecessor company of American Home Products (AHP: Research, Estimates), decided to cease production in 1995 rather than to make government-ordered improvements to its manufacturing plant after an FDA inspection found contaminants in the water supply.
The device earned perhaps its most enduring fame in an episode of the "Seinfeld" TV comedy, when the character Elaine, hoarding a dwindling supply of the discontinued product, went through agonies deciding whether the men she was dating were "sponge-worthy."
"'Seinfeld' has helped a whole lot" in preserving public awareness of the product, Detroyer said.
Discovering rights were available
The privately held Allendale Pharmaceuticals was already in startup mode, planning to commercialize some other patents in women's health, when the founders learned that rights to the sponge were available.
The FDA approval had never been withdrawn, so the only issue was to establish a manufacturing process that would meet the agency's standards.
"It was a bit of serendipity," Detroyer said. The company acquired the rights last March, believing the sponge to be "an excellent platform for other women's products."
And while it is likely to be several months yet before the product comes to market, "we are already feeling the demand," he said, with a steady stream of e-mails and phone calls inquiring about the device's availability.
He said he expected the device also to be available soon in Canada.