Biopharmaceutical company Galena Biopharma has launched Abstral (fentanyl) sublingual tablets in the United States. Abstral is indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain.
Galena acquired Abstral in March 2013 and since that time has scaled its field commercial team, manufactured the drug for commercial sale, secured broad access and reimbursement support from commercial and federal health insurance entities, implemented a robust patient assistance program, and developed a broad product distribution network. Abstral can be prescribed by healthcare professionals and is available to patients at all retail pharmacies nationwide.
"As an oncology company dedicated to improving patients' lives, we are thrilled to introduce Abstral as our first commercial product and offer cancer patients relief from their breakthrough pain," said Mark J Ahn, president and chief executive officer. "We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no speacial handling or disposal. We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena. I look forward to reporting our continued progress later this year."
Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. Breakthrough cancer pain occurs in the majority of patients who are already receiving chronic, long-acting opioid pain management and yet have episodes of severe tumour- and treatment-related cancer pain. Breakthrough pain occurs frequently in these patients, particularly as they try to conduct normal daily activities, with a mean number of episodes of four per day (range of 1-14 per day) and a median duration of 30 minutes (range of 1-240 minutes). The wide range of time to relief of these severe pain episodes leads to high levels of distress and impaired quality of life experienced by patients.