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Sublingual Fentanyl (Abstral) Launched in U.S. for Treatment of Breakthrough Cancer Pain
Abstral (fentanyl) Sublingual Tablets are now available in the U.S. The product is a sublingual fentanyl tablet indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant of, opioid therapy for their persistent baseline cancer pain.
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 most patients who are already receiving chronic, long-acting opioid pain treatment and yet have episodes of severe tumor- 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 4 per day (range, 1 to 14 per day) and a median duration of 30 minutes (range, 1 to 240 minutes). The wide range of time to relief of these severe pain episodes can lead to high levels of distress and impaired quality of life.
According to the product’s manufacturer (Galena Biopharma), the Abstral formulation delivers micronized fentanyl in a sublingual tablet, which dissolves under the tongue in seconds and provides relief of breakthrough pain in minutes.
Source: Galena Biopharma; October 3, 2013.