The FDA has approved Onsolis (fentanyl buccal soluble film, from BioDelivery Sciences International and Meda AB), formerly referred to as BEMA Fentanyl, for the management of breakthrough pain in patients ≥18 years of age with cancer, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Onsolis utilizes BioDelivery’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small dissolvable, polymer film for application to the buccal mucosa.

Onsolis is expected to be made available by Meda Pharmaceuticals in the fourth quarter of 2009, only through a restricted distribution program called the FOCUS (Full Ongoing Commitment to User Safety) Program and requires prescriber, pharmacy, and patient enrollment. The FOCUS program was created in accordance with the FDA’s requirements to help ensure that the benefits outweigh the risks of Onsolis. The program will facilitate appropriate use of Onsolis and provide healthcare practitioners, patients, and caregivers support through training and education.

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