US FDA approves Onsolis to manage breakthrough pain in cancer patients

BioDelivery Sciences International, Inc and Meda AB announced approval from the US Food and Drug Administration (FDA) to market Onsolis (fentanyl buccal soluble film), formerly referred to as Bema Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Onsolis is the first product to utilize the company's proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek).