Meda Pharmaceuticals introduces Onsolis for treating breakthrough cancer pain

Meda Pharmaceuticals Inc. today announced the launch of Onsolis(TM)( )(fentanyl buccal soluble film) in the U.S. 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 uses an innovative drug delivery technology called BioErodible MucoAdhesive (BEMA(TM)), developed by BioDelivery Sciences International, Inc. (BDSI). Onsolis consists of a small, dissolvable, polymer film, formulated with fentanyl, for application to the inner lining of the cheek.

Onsolis is available through a controlled distribution program called FOCUS(TM) (Full Ongoing Commitment to User Safety), the first opioid Risk Evaluation and Management Strategy (REMS) program that provides for prescriber, pharmacy, and patient enrollment for the integrated, coordinated safe use of Onsolis. The FOCUS Program was designed to meet requirements by the U.S. Food and Drug Administration (FDA) to help ensure appropriate use of Onsolis.

"The launch of Onsolis represents a significant achievement for Meda and an innovative pain management option for physicians to offer their patients with cancer who are experiencing breakthrough pain. The Onsolis technology differs from existing products used in these patients by virtue of its physical characteristics that enable patients to obtain the pain relief they need in a convenient delivery system," said Sharon Clarke, President, Meda Pharmaceuticals Inc. "We are proud of our work with the FDA on the development of FOCUS, a program that is designed to facilitate the appropriate use of Onsolis and to provide healthcare practitioners, patients, and caregivers with comprehensive training and information."

The goal of the FOCUS Program for Onsolis is to lessen the risk of Onsolis overdose, abuse, addiction, and serious complications due to medication errors by:

• Helping to assure proper patient selection, including avoidance of the use of Onsolis in opioid non-tolerant patients;
• Reducing the risk of exposure to Onsolis in persons for whom it was not prescribed, including accidental exposure in children; and
• Training prescribers, pharmacists, and patients about proper dosing and administration.