FDA Gives OK to Trial for BioDelivery Sciences Drug Delivery Technology

[Guest guest]

FDA Gives OK to Trial for BioDelivery Sciences Drug Delivery

Technology

http://www.localtechwire.com/business/local_tech_wire/biotech/story/1

193233/

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).