MORRISVILLE, N.C. – BioDelivery Sciences International, or BDSI, has received Food and Drug Administration approval to move to Phase I clinical trial of its novel drug delivery technology.

BDSI received notification last week of its new drug application from the FDA.

The company hopes to develop means of delivering drugs orally that are now only available through injection. Its Bioral cochleate delivery method involves encapsulating, protecting and delivering drugs that can’t be broken down by or absorbed through the gastrointestinal track.

BDSI’s lead product involves deliver of the drug Amphotericin B, an antifungicidal agent for treating infections of the esophagus. Such infections are found in HIV patients and patients receiving chemotherapy for cancer. The drug is also used to treat Leishmaniasis, which is contracted through parasites.

The development of Bioral® CAMB for fungal infections has been supported in part by the Division of AIDS, National Institutes of Allergy and Infectious Diseases and National Institutes of Health (NIH).