Fentanyl Sublingual Spray for Breakthrough Cancer Pain in Patients Receiving Transdermal Fentanyl

Abstract

Aim: To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP). Methods: Adults tolerating ATC opioids received open-label FSS for 26 days, followed by a 26-day double-blind phase for patients achieving an effective dose (100–1600 µg). Results: Out of 50 patients on ATC TFP at baseline, 32 (64%) achieved an effective dose. FSS effective dose moderately correlated with mean TFP dose (r = 0.4; p = 0.03). Patient satisfaction increased during the study. Common adverse event included nausea (9%) and peripheral edema (9%). Conclusion: FSS can be safely titrated to an effective dose for BTCP in patients receiving ATC TFP as chronic cancer pain medication. ClinicalTrials.gov identifier: NCT00538850

KEYWORDS:

• breakthrough cancer pain
• fentanyl sublingual spray
• transmucosal immediate-release fentanyl

Financial & competing interests disclosure

D Alberts has had a consulting or advisory role with Insys Therapeutics, Inc. (consultant, clinical research and drug development). CC Smith and N Parikh are employees of and hold stock in Insys Therapeutics, Inc. R Rauck has had a consulting or advisory role or received research funding from Medtronic, Inc., Medasys, Inc., the Alfred Mann Foundation, Archimedes, BioDelivery Sciences International, Inc., Meda and Jazz Pharmaceuticals, has been on speakers’ bureau for Jazz Pharmaceuticals and has received research funding from Alfred Mann Foundation, Bioness, Boston Scientific, Collegium Pharmaceuticals, CNS Therapeutics, Jazz Pharmaceuticals, Medtronic, Myoscience, NeurAxon, Inc., Spinal Restoration, Spinal Modulation and St Jude Medical. Funding for this study was provided by Insys Therapeutics, Inc., Chandler, AZ, USA. Two employees of the sponsor participated as authors of this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Technical editorial and medical writing assistance, under the direction of the authors, was provided by Mary Beth Moncrief, and Pratibha Hebbar, Synchrony Medical, LLC, West Chester, PA, USA. Funding for this support was provided by Insys Therapeutics, Inc.

Additional information

Funding

D Alberts has had a consulting or advisory role with Insys Therapeutics, Inc. (consultant, clinical research and drug development). CC Smith and N Parikh are employees of and hold stock in Insys Therapeutics, Inc. R Rauck has had a consulting or advisory role or received research funding from Medtronic, Inc., Medasys, Inc., the Alfred Mann Foundation, Archimedes, BioDelivery Sciences International, Inc., Meda and Jazz Pharmaceuticals, has been on speakers’ bureau for Jazz Pharmaceuticals and has received research funding from Alfred Mann Foundation, Bioness, Boston Scientific, Collegium Pharmaceuticals, CNS Therapeutics, Jazz Pharmaceuticals, Medtronic, Myoscience, NeurAxon, Inc., Spinal Restoration, Spinal Modulation and St Jude Medical. Funding for this study was provided by Insys Therapeutics, Inc., Chandler, AZ, USA. Two employees of the sponsor participated as authors of this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Technical editorial and medical writing assistance, under the direction of the authors, was provided by Mary Beth Moncrief, and Pratibha Hebbar, Synchrony Medical, LLC, West Chester, PA, USA. Funding for this support was provided by Insys Therapeutics, Inc.