Long-term nasal tolerability of fentanyl pectin nasal spray in breakthrough pain in cancer.

Abstract

e19604 Background: Previous randomized controlled studies have demonstrated that fentanyl pectin nasal spray (FPNS) offers pain improvement within 5 minutes with high patient acceptability. Given that FPNS is administered nasally, this report specifically evaluates long-term nasal tolerability. Methods: The 16-week, open-label study consisted of both newly titrated or rolled over patients with breakthrough pain in cancer (BTPc) from earlier controlled studies. Those experiencing 1–4 BTPC episodes/day while taking ≥60 mg/day oral morphine (or equivalent) were included. FPNS was used to treat ≤4 BTPc episodes/day. Nasal tolerability was assessed both by the clinician (nasal obstruction, inflammation, discharge, mucosal color) and by subjective patient assessments before the study at weeks 4, 8, 12, and 16, and at the final study visit to assess the following on a 4-point scale (0=absent, 3=severe): stuffy/blocked nose, runny nose, itching/sneezing, nose crusting/dryness, burning/discomfort, bleeding, cough, postnasal drip, sore throat, and taste disturbance. Results: This analysis included 403 patients. One hundred ten of those patients completed the study; 94% of 42,227 FPNS-treated episodes required no additional rescue medication. After titration to an effective dose, 90% of patients required no increase in FPNS dose over the study period overall. Of the newly enrolled patients, 87 had confirmed allergic/seasonal rhinitis; 72 (83%) were successfully titrated and entered the open-label study. Overall, objective and subjective nasal assessments showed no clinically significant effects. When subjective nasal assessments were averaged across BTPc episodes for each patient, all the parameters scored ≤0.2, with most symptoms rated absent to mild. Among treatment-related adverse events (TRAEs), nasal discomfort (2.2%) and rhinorrhea (1.2%) were reported by ≥1% patients. None of these TRAEs were considered severe. Conclusions: In a long-term, 16-week, open-label study, FPNS has been shown to provide consistent efficacy with no clinically significant nasal TRAEs. Such nasal tolerability has been confirmed through both objective and subjective assessments.