The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs

The aim of this paper was to assess the drug costs of the different biotechnologies (intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablet (FBT)) in the treatment of breakthrough cancer pain (BTCP). We have calculated the mean drug costs (expressed in euros (€)) for patients treated for BTCP. INFS resulted the less expensive towards OTFC and FBT, with 697 440 €versus (vs.) 809 552 €vs. 779 662 €every 100 patients treated for BTCP, respectively. In conclusion, combining drug costs of different biotechnologies (INFS, OTFC and FBT) with the measure of efficacy represented by the reduction of BTCP avoided (incremental cost-effectiveness ratio, ICER), INFS resulted in better cost-effectiveness.

Effect of fentanyl buccal tablet on pain-related anxiety: A 4-week open-label study among opioid-tolerant patients with chronic and breakthrough pain

Objective: To evaluate the effect of fentanyl buccal tablet (FBT) on pain-related anxiety in opioid-tolerant patients with chronic pain and breakthrough pain (BTP).Design: This study consisted of a screening visit, open-label titration period, and 4-week open-label treatment period.Setting: Thirty-one US study centers.Patients: Opioid-tolerant adults with chronic, persistent pain experiencing 1-4 BTP episodes per day at baseline. Two hundred eighteen patients were enrolled in this study; 180 completed the titration period; and 169 completed the treatment period.Intervention: Patients were treated with FBT (100-800 g) for BTP episodes for 4 weeks while continuing their around-the-clock opioid regimens.Main outcome measures: Change from baseline in the Pain Anxiety Symptoms Scale (PASS) total score at the final visit.Results: Based on a mean baseline PASS total score of 82.6, study patients had a high level of anxiety; 92 patients (42 percent) had a history of anxiety disorders. The change from baseline in PASS total score was not statistically significant (mean change, −1.6; p = 0.322). Numerical improvements were reported in some secondary measures (eg, Beck Depression Inventory total score [mean change, −1.1; p = 0.038]) and categorical measures (eg, Pain Flare Treatment Satisfaction, Patient Assessment of Function, and Clinician Assessment of Patient Function ratings). FBT was generally well tolerated, with no serious adverse events related to study drug.Conclusions: Four weeks of treatment with FBT did not reduce anxiety to a clinically meaningful extent, although improvement was reported in several secondary measures of functioning. Further research is needed to assess the impact of treatment for BTP on anxiety symptoms in opioid-tolerant patients with BTP.

Effect of prophylactic fentanyl buccal tablet (FBT) on exertional dyspnea in patients with cancer: A pilot double-blind, placebo-controlled, randomized trial.

10085 Background: Exertional dyspnea is one of the most common, debilitating and difficult-to-treat symptoms in cancer patients. Few clinical trials have been conducted. We tested the hypothesis that FBT, a rapid onset opioid, given prophylactically prior to exertion can improve exertional dyspnea. Methods: In this double-blind parallel (1:1) RCT, we asked cancer patients who were opioid-tolerant and had exertional dyspnea to complete a 6 minute walk test (6MWT) at baseline, and then randomly assigned them to either FBT proportional to 20-50% of daily dose or placebo 30 minutes before a second 6MWT. The primary outcome was a validated 11-point dyspnea NRS assessing dyspnea “now” (where 0 = none and 10 = worst possible) every minute during each 6MWT. Secondary outcomes included walk distance, vital signs and neurocognitive testing, adverse effects, and global impression. Ten evaluable patients in the FBT provided 80% power to detect an effect size as small as 1.0 using a two-sided paired t-test with a significance level of 5% to compare the change of dyspnea between the first and second walk tests. We compared the outcomes between the first and second 6MWTs using paired t-test. Results: Among 22 patients enrolled, 20 (91%) completed the study (9 FBT, 11 placebo). FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and 6 minutes (mean change -2.4, 95% confidence interval [CI] -3.5, -1.3) and respiratory rate (mean change -2.6, 95% CI -4.7, -0.4). Placebo was also associated with a non-statistically significant decrease in dyspnea (mean change -1.1). Between arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate -0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least “somewhat better” in the second 6MWT (4/9 vs. 0/11, P = 0.03). The other secondary outcomes did not differ significantly between arms. Conclusions: These data support our hypothesis that proportionally dosed FBT was associated with improvement in exertional dyspnea, and highlights the need for larger confirmatory trials. Clinical trial information: NCT01856114.