Fentanyl Sublingual Spray Shown to be Effective in Breakthrough Cancer Pain


HONOLULU, HI—Fentanyl sublingual spray can be safely titrated to an effective dose in patients with breakthrough cancer pain, a study presented at the American Pain Society's 31st Annual Scientific Meeting has found.

In fact, many patients prefer this treatment over previous medications for their pain, which is commonly managed with formulations of transmucosal fentanyl, noted Lisa Stearns, MD from the Center for Pain and Supportive Care, Scottsdale, AZ. Fentanyl sublingual spray, a novel sublingual formulation, has been developed to enhance rate and extent of fentanyl absorption and potentially the onset of analgesia.

They presented results from a 26-day open-label titration portion of a Phase 3, randomized, double-blind, placebo-controlled study enrolled opioid-tolerant patients with 1–4 episodes of breakthrough cancer pain per day. For randomization into double-blind treatment, patients must have successfully titrated to a fentanyl sublingual spray dose (100–1600mcg) that provided effective analgesia for two consecutive episodes of breakthrough cancer pain.

The Treatment Satisfaction Questionnaire for Medication was administered at baseline, prior to the first titration dose of fentanyl sublingual spray, to determine satisfaction with previous breakthrough cancer pain medication and at the end of titration to determine satisfaction with fentanyl sublingual spray.

Of 130 patients undergoing titration, 98 (75.4%) achieved a successful dose. Median dose was 800mcg; most common doses were 800mcg (24.5%) and 1200mcg (20.4%). Of 32 patients (24.6%) who withdrew from titration, only 3 (2.3%) were unable to establish an effective dose of fentanyl sublingual spray.

At the end of titration, 84.4% of patients were satisfied, very satisfied, or extremely satisfied with fentanyl sublingual spray in its ability to prevent/treat their condition and 87.5% with its ability to relieve symptoms compared with 36.7% and 27.3%, respectively, with their previous medication for breakthrough cancer pain.

At least one adverse event (AE) was reported by 78 patients (60%); AEs were rated with a maximum intensity of mild or moderate for 87.2% of patients who experienced an AE. The most common treatment-related AEs (≥5% of patients) were nausea (7.7%), somnolence (7.7%), dizziness (7.7%), and vomiting (5.4%). Serious AEs were observed in 7 patients (5.4%); however, none was considered by investigators to be related to the study medication and many were related to their cancer, including metastases and malignant neoplasm.

Patients rated interference from side effects as 20% and interference with mental function as 30% for fentanyl sublingual spray compared with 74.5% and 72.7%, respectively, for their previous medication for breakthrough cancer pain.