BREAKTHROUGH FOR CANCER PAIN.

Not every breakthrough is positive. Of the approximately 1.4 million new cancer patients in the U.S. each year, more than half experience pain associated with their disease. The patient's level of pain changes throughout the day, with many patients experiencing two kinds of chronic cancer pain: persistent pain and what is known as "breakthrough pain" (BTP).

While persistent, or continuous, pain can usually be controlled through a patient's daily pain medication regimen, breakthrough pain literally "breaks through" these therapeutic roadblocks and is not alleviated by regular doses of pain medication.

These intense episodes which arrive quickly and can last up to an hour occur even though a patient may be properly adhering to his or her pain medication regimen. BTP may be triggered by innocuous events such as coughing or sneezing, and sufferers typically experience between one and five episodes per day. Although patients can sometimes anticipate the onset of BTP, its sudden emergence can disrupt normal activity. Approximately 40% of cancer patients live with breakthrough pain on a daily basis.

BioDelivery Sciences International, Inc., a specialty biopharmaceutical company based in Raleigh, North Carolina, has developed BEMA Fentanyl, their lead product for the treatment of breakthrough cancer pain. BEMA (BioErodable MucoAdhesive) Fentanyl is effective in delivering a high strength opioid pain reliever, fentanyl, very quickly and conveniently. The BEMA technology utilizes a small, multilayered, water-soluble disc made up of cellulosic polymers that easily adheres to the inner cheek. Once the disc is attached to the inner buccal area (inner check) and moistened with saliva, the first layer delivers the drug into the bloodstream in a matter of minutes and then completely dissolves. There is a clear need and growing market for additional agents that can provide rapid pain relief for cancer patients," said Dr. Mark A. Sirgo, Pharm.D., Chief Executive Officer of BioDelivery Sciences. We believe that fentanyl, delivered with our proprietary BEMA disc technology, has the potential to meet an important patient need and will be well-suited for breakthrough cancer pain in opioid-tolerant patients." BDSI has completed Phase III efficacy and safety studies and filed the NDA (New Drug Application) with the FDA in October.

For more information, visit http://www.bdsinternational.com. or call 212/825-3210.