A Report on the Long-Term Use of Fentanyl Pectin Nasal Spray in Patients With Recurrent Breakthrough Pain

Context. As patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. Objectives. To investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy. Methods. Adult patients (N = 401) taking at least 60 mg/day oral morphine or equivalent, experiencing one to four episodes of BTPc a day, entered an open-label long-term study (NCT00458510). Patients had either completed an FPNS randomized controlled trial or were newly identified. Of these, 171 patients continued into an extension study. Up to four episodes of BTPc a day were treated with FPNS at 100-800 mu g titrated doses. During the extension study, patients visited the clinic every four weeks for assessment and reporting of adverse events (AEs). Results. There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for >= 360 days; the maximum duration was 44 months. Seventy percent of patients did not change their FPNS dose; 2% of patients withdrew from the study because of the lack of efficacy. The most common AEs, aside from disease progression, were insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of FPNS-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced nasal AEs, most of which were mild or moderate. Conclusion. FPNS appeared to provide sustained benefit and was well tolerated during long-term treatment of BTPc. (C) 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.