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Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP 
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Conflicts of interest Disclosure: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Davies has served as a consultant for Archimedes and received support from Archimedes to travel to meetings to present trial data. No other conflicts of interest were reported.
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Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Conflicts of interest Disclosure: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Davies has served as a consultant for Archimedes and received support from Archimedes to travel to meetings to present trial data. No other conflicts of interest were reported.
| |
Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Conflicts of interest Disclosure: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Davies has served as a consultant for Archimedes and received support from Archimedes to travel to meetings to present trial data. No other conflicts of interest were reported.
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