AB 11. Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with lung cancer and bone metastases

Background: Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. Oral opioids have traditionally been the only available drugs for BTcP. However, the onset and duration of action of oral opioids may not be suitable for treating many episodes of BTcP in patients with bone metastases that are of short onset and duration. Aim of this study was to investigate the efficacy and long-term tolerability of intranasal fentanyl spray (INFS) 50 to 200 microg in the treatment of breakthrough pain in opioid-tolerant patients with lung cancer and bone metastases.
Patients and methods: This was a non-randomized, study conducted in 53 patients (38 males-15 females mean age 69+/-5.3 yrs) with lung cancer and bone metastases, receiving a stable dose of long-term opioid treatment for the control of background pain. The study comprised a 2-week titration phase, followed by a maintenance phase of up to 3 months. The endpoint of interest was pain intensity difference [PID, reported on a 0-10 numeric rating scale (NRS)] up to 15 minutes after study drug administration. Patients were treated at home with their effective dose of INFS (50, 100, or 200 microg). Adverse events (AEs) were recorded in patient diaries and reported in monthly clinic visits.
Results: 46 patients completed the study. There was a statistically significant reduction of pain (PID) according to NRS, 15 minutes after INFS intake (5.11+/-1.18 vs. 8.96+/-0.63) (P=0.0001). This was maintained for any measured time point before 60 minutes after drug administration. The dose of INFS was 50 microg, in 13 pts 100 microg in 22 pts and 200 microg, in 11 pts. The most frequent AE reported was nausea (4 pts - 8.6%) mainly with the dose of 200 microg. The drug was well tolerated with no serious adverse events.
Conclusions: The use of fentanyl spray at doses of 50, 100, and 200 microg seems to be effective and safe for long-term treatment of BTcP episodes, in patients with lung cancer and bone metastases.