Raleigh-based Salix Pharmaceuticals announced today that is has submitted a new drug application to the Food and Drug Administration for Crofelemer, a drug used to treat chronic diarrhea in HIV/AIDS patients.

Salix has an agreement to develop Crofelemer with San Francisco-based Napo Pharmaceuticals. Napo, which sued Salix earlier this year claiming it breached their collaboration agreement, announced last month that it had terminated the agreement.

Salix calls the lawsuit baseless and says Napo's termination of the license is groundless and without merit.

The FDA now has 60 days to conduct a filing review to determine if Salix's application is complete enough to warrant a more substantive review of Crofelemer.

Family Health International, which is based in Research Triangle Park and works on reproductive health efforts around the world, was among the research groups involved in testing a topical gel that may protect some women from HIV infection.

Researchers announced today that the gel may, for the first time, offer a topical barrier to HIV. Women who used the gel, called PRO 2000, were 30 percent less likely to be infected with HIV than those who did not use it, according to findings presented at a medical conferences in Montreal, Canada.

Subsequent, larger studies will be conducted to test the gel's results.
“The entire field of HIV prevention research has been given a boost,” Dr. Ward Cates, president of Research at Family Health International, said in a prepared statement. “This is the first major study to show that a vaginal gel may prevent HIV infection in women. As with any initial scientific finding, additional clinical data is needed to fully demonstrate the effectiveness of this product.”

Family Health International served as the central coordinating and operations center for the study. The group developed the trial protocol and other study materials, helped obtain ethical and regulatory approvals, trained site study staff, and worked with the research team to assure study quality.