Rauck, R., Reynolds, L., Geach, J., Bull, J., Stearns, L., Scherlis, M., . . . Dillaha, L. (2012). Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: A randomized, double-blind, placebo-controlled study. Current Medical Research and Opinion, 28(5), 859–870.

To assess the efficacy of and determine the side effects related to the use of sublingual fentanyl spray for the treatment of breakthrough cancer pain  

The study involved an open-label titration period followed by a treatment period of up to 26 days. The primary efficacy measures were  summed pain intensity difference at 30 minutes (SPID₃₀), total pain relief at 30 minutes (TOTPAR₃₀), and patient global evaluation of medication study at 30 minutes. Efficacy was observed 5–60 minutes postdose and for side effects throughout. Patients were randomly assigned to the study drug or placebo. After the treatment period, a follow-up assessment was done 30 days after treatments. The fentanyl sublingual spray was titrated from 100 mcg to up to 1600 mcg until an effective dose was reached. Rescue medication was the medication the patient had for breakthrough pain before the study.

• The sample was composed of 130 patients, 98 in the placebo-controlled period. The final assessment was based on 90 patients.
• Mean patient age was 65 years.
• Of all patients, 46.9% were male and 53.1% were female.
• All patients had 1–4 episodes of breakthrough pain daily, which was partially controlled by means of at least five morphine equivalents of opioid.
• The most common cancers in the sample were breast, skin, lung, and head and neck cancers.

• Single site
• Inpatient and outpatient
• Center for Clinical Research, Winston-Salem, North Carolina, United States

• End-of-life care
• Clinical applications: end-of-life and palliative care, elderly care
   

Randomized, double-blind, placebo-controlled study 

• Summed pain intensity difference at 30 minutes (SPID₃₀)
• Total pain relief at 30 minutes (TOTPAR₃₀)

Of 130 patients, 98 entered the double-blind period. Relative to placebo, fentanyl sublingual spray significantly improved mean SPID scores from 5 minutes (p = 0.0219) through 60 minutes (p < 0.0001), including the primary endpoint at 30 minutes (p < 0.0001). The most frequent effective dose was 800 mcg. Side effects reported were nausea, hyperhidrosis, and peripheral edema; however, investigators did not consider any of these effects to be related to the treatment. Side effects occurred in about 4% of patients. Degree of pain relief and speed of pain relief were significantly higher with the study drug (p < 0.0001).

In this study fentanyl sublingual spray was well tolerated and effective in treating breakthrough of cancer pain.

Proper patient assessment prior to recommendation of the treatment is highly important. Oral hygiene is important during treatment with fentanyl spray. Keep an eye on side effects to ensure the comfort of the patient.