Advantage 24 nonoxynol-9 product discussed at meeting. Contraception (spermicides).

Abstract

Columbia Laboratories, Inc., Miami, Florida, reported safety data on the spermicidal product Advantage 24 that show it is safe even when administered four times a day, according to data from the UN Global Program on HIV/AIDS (UNAIDS) and the US National Institutes of Health (NIH). The data were reported at a meeting of the Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective Drugs, and Antiviral Drugs advisory committees of the US Food and Drug Administration. Because of its favorable safety profile, Advantage 24 was the only product that UNAIDS selected for testing to determine its effectiveness against the spread of sexually transmitted diseases (STDs). Therefore, in May 1996, Columbia Laboratories and UNAIDS announced the initiation of an international Phase III clinical study of Advantage 24 for the prevention of the heterosexual transmission of HIV and STDs in approximately 2000 women. Additionally, the NIH is performing similar testing in Africa. Advantage 24, which uses Columbia Laboratories' patented bioadhesive delivery system to deliver nonoxynol-9, currently is marketed in the US by Lake Pharmaceuticals, Inc., and in Canada by Roberts Pharmaceuticals, as a long-lasting, vaginally delivered spermicide, pursuant to strategic alliance agreements with Columbia Laboratories.