BEMA™ Technology

The BEMA™ drug delivery technology is a buccal soluble film

consisting of a small, bioerodible polymer film for application to the mucosal membranes (inner lining of cheek). BEMA™ films were designed to rapidly deliver a dose of drug across the mucous membranes for time sensitive conditions.

BEMA™ films are designed to:

• Adhere to oral mucosa in less than 5 seconds
• Optimize delivery across the oral mucosa
• Completely dissolve within 15 to 30 minutes

The first product utilizing the BEMA™ technology is Onsolis™ (fentanyl buccal soluble film). Onsolis™ is being developed for breakthrough pain in opioid tolerant patients with cancer. The BEMA™ technology may also be developed with other active drugs, particularly in conditions where rapid delivery of drug is important, oral dosing is not optimal, or where intravenous lines or injections are unavailable or not practical. BDSI owns the worldwide rights to the BEMA™ drug delivery technology.

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