Minkowitz, H., Bull, J., Brownlow, R.C., Parikh, N., & Rauck, R. (2016). Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. Supportive Care in Cancer, 24, 2669–2675. 

DOI Link

Study Purpose

To assess the long-term safety of fentanyl sublingual spray for breakthrough cancer pain

Intervention Characteristics/Basic Study Process

An initial titration phase was used to determine dosing for new patients. Additional patients were continued on the medication after their involvement in a prior double-blind randomized trial. The study was conducted for 90 days. Follow-up was conducted by telephone 30 days after trial completion or patient withdrawal. Study measures were obtained monthly.

Sample Characteristics

  • N = 163
  • MEAN AGE = 53.6 years
  • MALES: 47.6%, FEMALES: 52.4%
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Not provided
  • OTHER KEY SAMPLE CHARACTERISTICS: 20% were undergoing chemotherapy. Most had mild to moderate background pain and breakthrough episodes moderate in intensity for a duration of 60 minutes, which occurred a mean of three times daily.

Setting

  • SITE: Multi-site
  • SETTING TYPE: Not specified
  • LOCATION: United States, Canada, and India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Open label

Measurement Instruments/Methods

  • Adverse events
  • Treatment Satisfaction Questionnaire for Medication (TSQM)

Results

Of the patients, 80% achieved an effective dose during titration. The median effective dose was 600 mcg, and the range of daily dosing during maintenance was 140–9,381 mcg. Three patients had adverse events possibly related to the study medication, and 7.4% had application site irritation during the titration phase, but no patients had this problem during the maintenance phase. In addition, 87% were satisfied to extremely satisfied with effectiveness of the analgesia during the maintenance period.

Conclusions

Findings suggest that fentanyl submucosal spray is well tolerated over several months of use.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • No measurement of efficacy for pain—study objectives were just to evaluate safety

Nursing Implications

Findings suggest that submucosal fentanyl spray is well tolerated for relatively long-term use.