Biodelivery Sciences International

BioDelivery Sciences' strategy is to utilize patented and proprietary drug delivery technologies to create products and formulations that are targeted to significant market opportunities. Presently, these opportunities will be primarily centered on the BEMA™ and Bioral® technologies.

The BEMA™ drug delivery technology consists of a dissolvable, dime-sized polymer film for application to mucosal (inner lining of cheek) membranes. BEMA™ films were designed to deliver a dose of drug across mucous membranes.

BEMA™ Fentanyl is being developed for breakthrough pain in opioid tolerant patients with cancer. BEMA™ Fentanyl must not be used in the management of migraine, acute (including emergency room), postoperative, or dental pain. The BEMA™ technology may also be developed with other active ingredients for trauma cases where intravenous lines or injections are unavailable or not practical. BDSI owns the worldwide rights to the BEMA™ drug delivery technology.

BEMA™ Fentanyl is currently not approved for use. BEMA™ Fentanyl is under FDA review only for the management of breakthrough pain in opioid tolerant patients with cancer. BEMA™ Fentanyl must only be used in opioid tolerant patients because life-threatening respiratory depression could occur at any dose in patients not taking chronic opiates. BEMA™ Fentanyl is contraindicated in the management of migraine, acute (including emergency room), postoperative, or dental pain. Patients and their caregivers must be instructed that BEMA™ Fentanyl contains a medicine in an amount which can be fatal to a child. All BEMA™ Fentanyl units must be kept out of the reach of children.

The Bioral® drug delivery technology encapsulates the selected drug in a nanocrystalline structure termed a “cochleate” cylinder. All of the components of the cochleate cylinder are naturally occurring substances. It is believed that the cochleate cylinder provides an effective delivery mechanism without forming a chemical bond, or otherwise chemically altering, the selected drug. The Bioral® drug delivery technology was developed in collaboration with the University of Albany and the University of New Jersey Medical and Dental School, each of which has granted us the exclusive worldwide licenses under applicable patents.

BDSI Technology