EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled,

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EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial Steffen T. Simon, MD, MSc, Marianne Kloke, MD, Bernd Alt-Epping, MD, Jan Gärtner, MD, Martin Hellmich, Dr rer med, Dipl Math oec, Rebecca Hein, Dr sc hum, Dipl Math oec, Maren Piel, Oliver A. Cornely, MD, FACP, FIDSA, Friedemann Nauck, MD, Raymond Voltz, MD Journal of Pain and Symptom Management Volume 52, Issue 5, Pages 617-625 (November 2016) DOI: 10.1016/j.jpainsymman.2016.05.023 Copyright © 2016 Terms and Conditions

Fig. 1 Titration phase for FBT and IRM. The initial dose of IRM was one-sixth of the patient's daily oral morphine equivalent dose (DOME) based on recommendation in the literature.17 ED = episodic dyspnea; EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; TPh = titration phase. Journal of Pain and Symptom Management 2016 52, 617-625DOI: (10.1016/j.jpainsymman.2016.05.023) Copyright © 2016 Terms and Conditions

Fig. 2 Trial flowchart. AE = adverse event; EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; R = randomization; SAE = serious adverse event; TPh = titration phase; V = visit. Journal of Pain and Symptom Management 2016 52, 617-625DOI: (10.1016/j.jpainsymman.2016.05.023) Copyright © 2016 Terms and Conditions

Fig. 3 Flow diagram. EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; ITT = intention-to-treat; TPh = titration phase. Journal of Pain and Symptom Management 2016 52, 617-625DOI: (10.1016/j.jpainsymman.2016.05.023) Copyright © 2016 Terms and Conditions

Fig. 4 Breathlessness intensity of episodes (NRS 0–10) from 0 to 60 minutes after study drug administration. FBT = fentanyl buccal tablet; IRM = immediate-release morphine; NRS = Numeric Rating Scale 0–10. Journal of Pain and Symptom Management 2016 52, 617-625DOI: (10.1016/j.jpainsymman.2016.05.023) Copyright © 2016 Terms and Conditions