BDSI Seeks OK of Oral Anti-Fungal Drug

U.S. firm BDSI said Friday the Food and Drug Administration has accepted its marketing application for its anti-fungal Bioral Amphotericin.

The company said the treatment for which it is seeking FDA approval is an oral version of its intravenous-administered Amphotericin B (CAMB), which it said is a potent, broadly active antifungicidal agent for treating infections such as esophageal candidiasis, an infection common in HIV patients and in patients getting chemotherapy for cancer.

The therapy also shows promise against other infections like the parasitic disease Leishmaniasis, which affects an estimated 2 million people worldwide, BDSI said.

The IV-based Amphotericin B products currently marketed are effective but limited in their use, due to the need for IV administration, as well as toxicity and cost issues, BDSI added.

CAMB would be the first broadly effective oral antifungicidal agent available in the world, if clinical trials are successful and the product achieves marketing approval, said Mark Sirgo, president and chief executive officer of BDSI. As such, it could have a major impact on the treatment and prophylaxis of fungal infections.