FDA Accepts BDSI Antifungal Drug for Review
Posted on: Friday, 2 February 2007, 12:00 CST
BioDelivery Sciences International has reported the filing and acceptance by the FDA of its investigational new drug application for Bioral cochleate drug delivery technology.
The Bioral product for which the application was filed is an enchocleated version of amphotericin B (CAMB), an antifungicidal agent. Amphotericin B is used for treating infections such as esophageal candidiasis, an infection prevalent in HIV patients and patients receiving cancer chemotherapy and leishmaniasis, a parasitic disease.
"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. As such it could have a major impact on the treatment and prophylaxis of fungal infections," said Dr Mark Sirgo, president and CEO of BDSI.
While highly effective, the use of the currently available Amphotericin B products on the market is limited by the requirement for intravenous administration, toxicity and cost.
Bioral cochleate technology has the potential to transform drugs, such as amphotericin B, which are currently available only by injection, into patient friendly, orally available products.
Cochleates are designed to encapsulate, protect and deliver certain drug molecules that are either broken down by gastrointestinal enzymes and acids, or cannot be absorbed through the gastrointestinal tract.
Source: Datamonitor
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