Effective Dose Titration of Fentanyl Sublingual Spray in Patients With Breakthrough Cancer Pain.
OBJECTIVE
To further describe effective dose titration of fentanyl sublingual spray to treat breakthrough cancer pain (BTCP) during the 26-day open-label titration phase of a phase 3, randomized, double-blind, placebo-controlled study.


METHODS
Opioid-tolerant patients with 1 to 4 episodes of BTCP per day were enrolled. For randomization into double-blind treatment, patients must have titrated to a dose (100 to 1,600 mcg) providing effective analgesia for 2 consecutive BTCP episodes. The Treatment Satisfaction Questionnaire for Medication was administered at baseline and at titration end and included a Global Satisfaction domain.


RESULTS
Of 130 patients undergoing titration, 98 (75%) achieved pain relief (median dose = 800 mcg). The most common doses that allowed for adequate pain relief were 800 mcg (24.5%) and 1,200 mcg (20.4%). Of 32 (25%) patients who withdrew from the study, only 3 (2.3%) did not achieve an effective dose. In patients attaining an effective dose, mean Global Satisfaction increased from 54.9 ± 2.1 at baseline to 75.3 ± 1.7 at the end of the titration phase. Seventy-eight patients (60%) reported ≥ 1 adverse event (AE). Thirty-three AEs (25.4%) were considered probably related to treatment, with nausea (6.2%) and somnolence (4.6%) most commonly reported.


CONCLUSIONS
In patients with BTCP, fentanyl sublingual spray can be rapidly and safely titrated to an effective dose, resulting in greater satisfaction with fentanyl sublingual spray than previous BTCP medications.
Carolinas Pain Institute and The Center for Clinical Research, Winston Salem, North Carolina, U.S.A.
Richard
R
Rauck
Four Seasons Hospice and Palliative Care, Flat Rock, North Carolina, U.S.A.
Janet
J
Bull
Insys Therapeutics, Inc., Chandler, Arizona, U.S.A.
Neha
N
Parikh
Insys Therapeutics, Inc., Chandler, Arizona, U.S.A.
Larry
L
Dillaha
The Center for Pain and Supportive Care, Scottsdale, Arizona, U.S.A.
Lisa
L
Stearns
breakthrough; cancer; fentanyl; pain; satisfaction; sublingual