Nalamachu, S., Hassman, D., Wallace, M.S., Dumble, S., Derrick, R., & Howell, J. (2011). Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Current Medical Research and Opinion, 27(3), 519–530.doi: 10.1185/03007995.2010.545380
To evaluate the long-term effectiveness of sublingual fentanyl orally disintegrating tablets (ODTs) for the treatment of breakthrough cancer pain in opioid-tolerant patients
The study comprised a two-week titration phase to establish an effective dose of sublingual fentanyl ODT. If an effective dose was achieved, the patient entered a maintenance phase that lasted up to 12 months. During the maintenance phase, patients self-administered sublingual fentanyl ODTs at the dose identified in the titration phase. Effectiveness of pain regimen was assessed at screening and at each monthly visit.
Multisite (44 sites in the United States)
Nonrandomized, open-label, phase III study
Sublingual fentanyl ODT may provide effective analgesia while maintaining quality of life during long-term treatment of breakthrough cancer pain.
Study of a larger and more racially diverse patient population, over a longer period of time, is required. Additional research in a palliative care setting may be warranted.