PMID- 26780504 OWN - NLM STAT- MEDLINE DCOM- 20170529 LR - 20181202 IS - 1433-7339 (Electronic) IS - 0941-4355 (Linking) VI - 24 IP - 6 DP - 2016 Jun TI - Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. PG - 2669-75 LID - 10.1007/s00520-015-3056-3 [doi] AB - PURPOSE: The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP). METHODS: This open-label, multicenter study enrolled both de novo and rollover patients who completed a double-blind, efficacy trial. Eligible patients were >/=18 years of age and experiencing pain that was being managed with an around-the-clock opioid yet were experiencing /=60 mg/day oral morphine or an equivalent dose of another opioid for >/=1 week). De novo patients initially entered a 21-day titration period to identify an effective dose of fentanyl sublingual spray (100-1600 mug), then entered a 90-day maintenance period. The incidence of adverse events (AEs), results of laboratory tests, vital sign assessments, and treatment satisfaction were assessed. RESULTS: Of the 269 patients (de novo, 179; rollover, 90) who entered the maintenance period, 163 (60.6 %) completed the study; the primary reason for discontinuation was an AE (22.3 %). Eighty percent of patients identified an effective dose of fentanyl sublingual spray (median dose, 600 mug). The most common AEs differed from the titration period (nausea (13 %), vomiting (12 %), and somnolence (10 %)) to the maintenance period (malignant neoplasm progression (24 %), vomiting (16 %), and peripheral edema (12 %)). Few changes in laboratory parameters and vital sign assessments were observed. Patients generally reported being more satisfied with fentanyl sublingual spray than with their previous BTCP treatment. CONCLUSIONS: This long-term maintenance study demonstrated that fentanyl sublingual spray was generally safe and well tolerated for managing BTCP over a 90-day period. FAU - Minkowitz, Harold AU - Minkowitz H AD - Department of Anesthesiology, Memorial Herman Memorial City Medical Center, 921 Gessner Road, Houston, TX, 77024, USA. Harold@Minkowitzmd.com. FAU - Bull, Janet AU - Bull J AD - Four Seasons Hospice and Palliative Care, Flat Rock, NC, USA. FAU - Brownlow, R Charles AU - Brownlow RC AD - Better Health Clinical Research, Newnan, GA, USA. FAU - Parikh, Neha AU - Parikh N AD - Clinical Operations, INSYS Therapeutics, Inc., Chandler, AZ, USA. FAU - Rauck, Richard AU - Rauck R AD - Medical Department, Carolinas Pain Institute and The Center for Clinical Research, Winston Salem, NC, USA. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20160116 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Analgesics, Opioid) RN - UF599785JZ (Fentanyl) SB - IM MH - Administration, Sublingual MH - Adult MH - Aged MH - Analgesics, Opioid/administration & dosage/*adverse effects MH - Breakthrough Pain/*drug therapy MH - Cancer Pain/*drug therapy MH - Double-Blind Method MH - Female MH - Fentanyl/administration & dosage/*adverse effects MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged OTO - NOTNLM OT - Breakthrough pain OT - Cancer pain OT - Fentanyl sublingual spray OT - Opioids EDAT- 2016/01/19 06:00 MHDA- 2017/05/30 06:00 CRDT- 2016/01/19 06:00 PHST- 2015/10/27 00:00 [received] PHST- 2015/12/07 00:00 [accepted] PHST- 2016/01/19 06:00 [entrez] PHST- 2016/01/19 06:00 [pubmed] PHST- 2017/05/30 06:00 [medline] AID - 10.1007/s00520-015-3056-3 [pii] AID - 10.1007/s00520-015-3056-3 [doi] PST - ppublish SO - Support Care Cancer. 2016 Jun;24(6):2669-75. doi: 10.1007/s00520-015-3056-3. Epub 2016 Jan 16.