Biodelivery Sciences International

BDSI's BEMA™ drug delivery technology consists of a dissolvable, dime-sized polymer unit for application to mucosal (inner lining of cheek) membranes. BEMA™ units were designed to deliver a dose of drug across mucous membranes.

BDSI's lead BEMA™ product under development is BEMA™ Fentanyl. BEMA™ Fentanyl is being developed for “breakthrough” pain (i.e., episodes of severe pain which “break through” the medication used to control the persistent 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. A New Drug Application (NDA) for BEMA™ Fentanyl for the management of breakthrough pain in opioid tolerant patients with cancer is under review at FDA.

The BEMA™ technology may also be developed with other active ingredients for trauma cases where intravenous lines or injections are unavailable or not practical.

Subsequent products in the BEMA™ system may include BEMA™ Buprenorphine for a broader range of pain conditions including post operative and chronic pain due to osteoarthritis, lower back disorders and rheumatoid arthritis; and BEMA™ Zolpidem for the treatment of insomnia.

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.

BEMA™ Technology