Long-term safety, tolerability, and acceptability of fentanyl pectin nasal spray in the treatment of breakthrough cancer pain.
Authors: A. W. Burton, N. Y. Gabrail, L. Radbruch, D. Taylor, E. Reyes, R. Portenoy
Journal: Journal of Clinical Oncology (2010)

9094^ Background: Previous studies have shown that fentanyl pectin nasal spray (FPNS) rapidly provides clinically meaningful pain relief in the treatment of breakthrough cancer pain (BTCP). This study assessed the long-term safety, tolerability, and acceptability of FPNS in patients with BTCP. Methods: Patients (newly titrated or rolled over from earlier controlled studies) with cancer experiencing 1–4 episodes/day of BTCP while taking ≥60 mg/day oral morphine (or equivalent) for cancer pain were eligible to enter an open-label safety study consisting of a 16-week initial phase and an extension phase. FPNS was used to treat up to 4 BTCP episodes/day. Safety and tolerability were assessed by adverse events (AEs), withdrawal due to AEs, and objective and subjective nasal assessments. Acceptability assessments included use of additional rescue medication and ratings of overall satisfaction with each treated episode and ratings of the ease of use and the convenience of FPNS. Results: 403 patients (234 new, 47 exposed to FPNS during titration but not entered into the treatment phase, 122 rolled over) were included in the safety analysis (42,227 episodes), with 110 patients completing 16 weeks. Mean duration of treatment was 60 days. 24.6% patients reported treatment-emergent AEs that were generally mild/moderate and typical of opioids. 1 of 80 deaths during the study was assessed as possibly related to study drug (constipation, intestinal perforation, peritonitis). Nonfatal serious AEs were reported in 61 (15.1%) patients—6 possibly and 1 probably related to study drug. Of the 20 patients who discontinued treatment due to AEs, 9 had possibly study drug–related AEs. Objective and subjective nasal assessments revealed no significant effects. 94% of FPNS-treated episodes required no rescue medication. Patients reported overall satisfaction with FPNS for 89.7% of episodes. At week 12, 96.9% of patients were satisfied with the ease of use and 97.9% with the convenience of FPNS. Conclusions: FPNS was safe and well tolerated both systemically and nasally. Overall, FPNS was well accepted and delivered consistent and reliable clinical effects that were sustained through up to 4 months of BTCP treatment. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Archimedes Archimedes Archimedes In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519-521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2010 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest.