Newswise — “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 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.
“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. Andrew Finn, BDSI Executive Vice President of Product Development. “Cancer patients with this kind of pain should discuss various options with their treating physician.”
While there are two breakthrough cancer pain products containing fentanyl already on the market—one a lozenge, the other a buccal tablet—the delivery system of ONSOLIS makes it unique. ONSOLIS uses the BioErodible MucoAdhesive (BEMA®) drug delivery technology that consists of a small, water-soluble, polymer film that is applied to the inside of the cheek (buccal mucosa). The fentanyl buccal soluble film adheres to the buccal mucosa in seconds, dissolves within fifteen to thirty minutes, and is designed to optimize delivery of fentanyl across the buccal mucosa.
At the time of the FDA approval, BDSI also announced the launch of its FOCUS™ (Full Ongoing Commitment to User Safety) Program for ONSOLIS, the first opioid Risk Management and Evaluation Strategy (REMS). “The goal of the FOCUS Program for ONSOLIS is to mitigate the risk of ONSOLIS overdose, abuse, addiction, and serious complications due to medication errors,” said Dr. Andrew Finn, BDSI Executive Vice President of Product Development. “The 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.”
While ONSOLIS™ is BDSI’s first FDA approved product, its regulatory passage represents an important validation of the company’s unique BEMA drug delivery technology. “With the approval of ONSOLIS, we have validated the utility of the BEMA drug delivery technology and demonstrated our ability to move a product through clinical development and the regulatory requirements set by FDA,” said Dr. Finn. “We now look forward to replicating our performance and regulatory achievements as we progress our pipeline. We are currently working on BEMA Buprenorphine, our second pain product, which is a form of buprenorphine that will also be delivered from a buccal soluble film placed on a patient’s buccal mucosa. The company also plans to use the BEMA technology to deliver other drugs that are not available in oral formulations due to their poor oral bioavailability and/or the need for a quick onset.”
For those covering this news, BioDelivery Sciences International. Inc. makes available Executive Vice President of Product Development Andrew Finn, Pharm. D., to discuss a variety of topics including:
• What is Breakthrough Cancer Pain (BTP), and why aren’t cancer patients being prescribed this class of drugs as often as one might expect?
• Generally speaking, why do you suspect that oncologists in particular are not routinely recognizing and treating breakthrough cancer pain?
• How does ONSOLIS™ work and how is it different from other products already on the market?
• Please describe the BEMA drug delivery technology and its potential future applications.
Expert Biography – Andrew Finn, Pharm. D., BioDelivery Sciences International, Inc. Executive Vice President of Product DevelopmentAndrew Finn, Pharm.D. is the Executive Vice President of Product Development. Dr. Finn has more than twenty-five years of experience in pharmaceutical development, and is responsible for the development of BioDelivery Sciences’ portfolio of products including ONSOLIS and BEMA Buprenorphine, including pharmaceutical development and manufacturing, nonclinical and clinical development, and regulatory affairs. Dr. Finn was previously the Executive Vice President of Product Development at POZEN, Inc., where he was responsible for the development of two migraine products. He was also the co-founder and Chief Executive Officer of enVision Sciences, a regulatory and clinical service company. Additional previous experience includes his role as the Vice President of U.S. Clinical Research for Solvay Pharmaceuticals, and a number of positions with increasing responsibility during his tenure at Glaxo, Inc. Dr. Finn received his Bachelor of Science in Pharmacy from the University of North Carolina and his Doctorate from the University of Michigan.
About BioDelivery Sciences International, Inc.BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI’s pain franchise utilizes the Company’s patented BEMA buccal soluble film technology and currently consists of: ONSOLIS (fentanyl buccal soluble film) a treatment for “breakthrough” pain in opioid tolerant patients with cancer, and BEMA Buprenorphine, a second analgesic in development with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA and Bioral® technologies on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina. For more information please visit www.biodeliverysciences.com.
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