VLI Corp., the Irvine manufacturer of the Today contraceptive sponge, has requested federal approval to begin human testing of a new sponge product for the treatment of vaginal infections, the company said Monday.
If the human tests prove effective, the company hopes to benefit from an accelerated testing process and begin sharing in a $60-million-a-year market for vaginal medications by mid-1987.
VLI is waiting for a green light from the U.S Food and Drug Administration to begin testing the laboratory-developed product in clinics in the United States and Europe. If the tests prove successful, therapeutic vaginal sponges containing time-released drugs could be purchased by prescription in two years rather than after the normal five-year testing period, according to Ken Berger, a biochemist and VLI's vice president of research and development.
Berger said VLI hopes to apply the same technology and time-release capabilities employed in the Today sponge to treat vaginal infections. "Instead of a spermicide in the sponge, we will use drugs that have therapeutic value," he said.
Until now vaginal infections have been treated by drugs that are taken orally or applied by creams and suppositories. By applying medication directly to the infected area with sponges, Berger said, "we feel we can use much less drugs and give comparable or superior effectiveness."
He said VLI believes the sponges can eliminate the toxic effects on the gastrointestinal system and liver that are sometimes caused by the absorption of infection-combating drugs when taken orally.
Berger said VLI filed its application for human test permission on April 15 after two years of laboratory testing, including animal experiments. The company wants to test the sponges, containing the drug metronidazole , in the treatment of Gardnerella vaginalis , the most common form of vaginal infection, afflicting between 7 million and 10 million women in the United States each year.
Berger said VLI also has applied to test the metronidazole-treated sponges to combat a common sexually transmitted disease called anti-trichomonas , which annually affects between 2 million and 3 million American women.
Berger said other drug products currently used to treat the two vaginal infections represent a $60-million-a-year retail market.
VLI could use a big share of that market. The company lost $6.1 million in 1984 and $359,625 in the first quarter of 1985--losses that company officials attribute largely to the costs of advertising and promoting VLI's contraceptive sponge. They say that sales of products which the company transfers from the laboratory to the marketplace in the future--products like the proposed therapeutic sponge--eventually will turn VLI around.
Because the FDA already has approved both the technology and the drug which are combined in VLI's new sponge therapy, Berger said, the company expects to obtain the agency's blessing after two years of testing, rather than the usual five. If the FDA gives a go-ahead, he said, the product will be tested in eight to 10 clinical centers in the United States and two to four clinics in Europe. Between 800 and 1,000 patients will be involved in the testing, he said.
VLI also plans to apply for government approval to introduce the therapeutic sponges in European countries, said Berger. It is likely, he added, that the sponges will be sold first in some European countries which have a more streamlined approval process than the United States.
Berger said VLI is moving ahead with laboratory development of sponge-applied drugs to treat other vaginal disorders, including fungus infections. Because of the prevalence of such vaginal diseases, he said, "the market potential is probably as great or greater than the vaginal contraceptive market."