Breakthrough Cancer Pain Meets Its Sticking Point.

RALEIGH, N.C. -- "Breakthrough pain" (BTP) is a common, debilitating feature of chronic pain that frequently afflicts cancer patients. While persistent, or continuous, pain can usually be controlled through a patient's normal oral pain medication regimen, breakthrough pain literally "breaks through" regular doses of pain medication.

Breakthrough pain can be sudden in onset and the pain very severe. If untreated or treated inadequately, BTP is often a disabling problem for patients with cancer. It can have a significant negative impact on physical functioning, psychological well being, and sleep. In addition, patients with cancer-related BTP are more likely to have pain-related hospitalizations and emergency room visits than patients without BTP.

Developed by Raleigh, North Carolina-based BioDelivery Sciences International, Inc., Onsolis[TM] is an opioid analgesic currently under review by the FDA for the potential management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Onsolis utilizes the BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film that is applied to the buccal membranes, or inner cheek lining. The film is specially designed to adhere to the inner cheek within seconds, bioerodes within fifteen to thirty minutes, and is designed to optimize fentanyl delivery across the mucous membranes.

While there are two fentanyl breakthrough cancer pain products already on the market--one a fentanyl lozenge, the other an effervescing tablet--the delivery system for Onsolis makes it unique. BEMA delivery technology may offer more convenience, be harder to misuse, and cause little irritation to the inside of the mouth. Onsolis has undergone two Phase III clinical trials in opioid tolerant adult cancer patients experiencing breakthrough cancer pain, and is currently not approved for use; if approved by FDA, Onsolis will be commercialized in the U.S. by Meda Pharmaceuticals.

"Many cancer patients that are already following a course of opioid analgesics do not understand why they still may be experiencing periodic sharp spikes in pain," said Dr. Richard L. Rauck, Executive Director of the Carolinas Pain Institute and for the Center for Clinical Research, a center that participated in the Phase III trials for Onsolis. "Cancer patients with this kind of pain should discuss various options with their treating physician. These patients might someday benefit from a product like Onsolis." Visit http://irgnews.com/coi/BDSI to learn more.