Minkowitz, H., Bull, J., Brownlow, R.C., Parikh, N., & Rauck, R. (2016). Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. Supportive Care in Cancer, 24, 2669–2675.
To assess the long-term safety of fentanyl sublingual spray for breakthrough cancer pain
An initial titration phase was used to determine dosing for new patients. Additional patients were continued on the medication after their involvement in a prior double-blind randomized trial. The study was conducted for 90 days. Follow-up was conducted by telephone 30 days after trial completion or patient withdrawal. Study measures were obtained monthly.
Of the patients, 80% achieved an effective dose during titration. The median effective dose was 600 mcg, and the range of daily dosing during maintenance was 140–9,381 mcg. Three patients had adverse events possibly related to the study medication, and 7.4% had application site irritation during the titration phase, but no patients had this problem during the maintenance phase. In addition, 87% were satisfied to extremely satisfied with effectiveness of the analgesia during the maintenance period.
Findings suggest that fentanyl submucosal spray is well tolerated over several months of use.
Findings suggest that submucosal fentanyl spray is well tolerated for relatively long-term use.