Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain

This open-label study evaluated the long-term safety and tolerability of or al transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-bas ed practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrou gh pain, and had achieved relief of their breakthrough pain with an opioid. Patients received OTFC units at a starting dosage strength determined in t he short-term trial (200-1600 mug). Outcome measures included number of suc cessfully treated breakthrough pains, global satisfaction rating (0 =or thr ough 4 = excellent), and side effects. In total, 41,766 units of OTFC were used to treat 38,595 episodes of breakthrough pain in 155 patients. Number of treatment days ranged from 1 to 423 (mean, 91 days). Patients averaged 2 .9 breakthrough pain episodes per day. About 92% of episodes were successfu lly treated with OTFC and there was no trend toward decreased effectiveness over time. Most patients (61%) did not require dose escalation during trea tment. Global satisfaction ratings were consistently above 3, indicating ve ry good to excellent relief. Common adverse events associated with OTFC wer e somnolence (9%), constipation (8%), nausea (8%), dizziness (8%), and vomi ting (5%). Six patients (4%) discontinued therapy due to an OTEC-related ad verse event. There were no reports of abuse and no concerns about the safet y of the drug raised by patients or families. OTFC was used safely and effe ctively during long-term treatment of breakthrough pain in cancer patients at home. J Pain Symptom Manage 2001;22:575-583. (C) U.S. Cancer Pain Relief Committee, 2001.