The use of Instanyl® in the treatment of breakthrough pain in cancer patients: a 3-month observational, prospective, cohort study

Support Care Cancer. 2014 Jun;22(6):1655-62. doi: 10.1007/s00520-014-2128-0. Epub 2014 Feb 8.


Purpose: Instanyl® (intranasal fentanyl spray) is a novel treatment for breakthrough pain (BTP) in cancer patients. It has shown a rapid onset of pain relief in clinical trials. This study examines the use of Instanyl® in real-life settings.

Methods: A 3-month observational, prospective, cohort study of cancer patients with BTP receiving Instanyl® (50, 100, or 200 μg) under routine clinical practice. Data were collected at three time points corresponding with routine clinic visits - baseline, Week 4, and Week 13.

Primary outcomes: success of titration and maintenance dose after titration.

Secondary outcomes: change in maintenance dose of Instanyl® and level of background pain medication; Brief Pain Inventory--Short Form (BPI-SF) and Patient Treatment Satisfaction Scale (PTSS) scores; adverse drug reactions (ADRs).

Results: Titration with Instanyl® was successful in 84.5 % of 309 patients; most patients were titrated at the lowest dose (50 μg). The majority showed no change in maintenance dose, with little change in the level of background pain medication. BPI-SF and PTSS scores significantly improved from baseline to Week 4. The main reason for terminating Instanyl® was death, as expected due to the underlying disease; incidence of ADRs was low and no fatal ADRs were reported.

Conclusions: In a real-life group of cancer patients with disease progression, Instanyl® was titrated successfully at doses <200 μg in the majority of patients, requiring only one dose, with no further change in maintenance dose. Pain severity, impact of pain on daily life, and treatment satisfaction significantly improved with Instanyl® treatment. No unexpected ADRs occurred.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Aged
  • Analgesics, Opioid / administration & dosage*
  • Analgesics, Opioid / adverse effects
  • Breakthrough Pain / drug therapy*
  • Female
  • Fentanyl / administration & dosage*
  • Fentanyl / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Nasal Sprays
  • Neoplasms / complications*
  • Prospective Studies


  • Analgesics, Opioid
  • Nasal Sprays
  • Fentanyl