Harold Minkowitz1, Janet Bull2, R Charles Brownlow3, Neha Parikh4, Richard Rauck5. 1. Department of Anesthesiology, Memorial Herman Memorial City Medical Center, 921 Gessner Road, Houston, TX, 77024, USA. Harold@Minkowitzmd.com. 2. Four Seasons Hospice and Palliative Care, Flat Rock, NC, USA. 3. Better Health Clinical Research, Newnan, GA, USA. 4. Clinical Operations, INSYS Therapeutics, Inc., Chandler, AZ, USA. 5. Medical Department, Carolinas Pain Institute and The Center for Clinical Research, Winston Salem, NC, USA.
Abstract
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 ≤4 BTCP episodes daily and were opioid-tolerant (i.e., receiving ≥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 μg), 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 μg). 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.
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 ≤4 BTCP episodes daily and were opioid-tolerant (i.e., receiving ≥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 μg), 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 μg). 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.
Entities:
Keywords:
Breakthrough pain; Cancer pain; Fentanyl sublingual spray; Opioids
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