Intranasal fentanyl spray: a novel dosage form for the treatment of breakthrough cancer pain.

OBJECTIVE

To review the pharmacology, pharmacokinetics, clinical efficacy, adverse events, dosing, and administration of intranasal fentanyl spray in the treatment of breakthrough cancer pain (BTCP) in adults.

DATA SOURCES

Relevant published data were identified using PubMed from inception to April 2012 using the search terms fentanyl nasal spray, intranasal fentanyl, intranasal fentanyl cancer pain, and fentanyl pectin cancer pain. Only articles evaluating the use of intranasal fentanyl spray for cancer pain were selected.

STUDY SELECTION AND DATA EXTRACTION

All articles evaluating the pharmacokinetics of intranasal fentanyl or the clinical efficacy of intranasal fentanyl spray for the treatment of BTCP were considered; references of selected articles were manually reviewed to identify further articles. The manufacturer of intranasal fentanyl spray was also contacted to obtain information.

DATA SYNTHESIS

Intranasal fentanyl spray gained Food and Drug Administration approval for the treatment of BTCP in adults with cancer receiving stable background opioid therapy for chronic pain. In doses ranging from 100 to 800 μg/spray, intranasal fentanyl spray was found to be more effective than placebo and more effective than oral morphine or oral fentanyl formulations in reducing pain for up to 15-45 minutes; onset of analgesia was also improved with intranasal fentanyl spray. The most commonly observed adverse events included nausea, vomiting, vertigo, and dizziness.

CONCLUSIONS

For the treatment of BTCP, intranasal fentanyl spray offers improved onset of analgesia compared to other oral therapies; this improved onset of analgesia may closely mimic the typical time course of a BTCP episode. Nasal administration may overcome problems such as nausea, vomiting, or xerostomia that may complicate oral administration of analgesics. Potential disadvantages include uncertainty in treating more than 4 BTCP episodes per 24 hours and a higher cost compared to generically available oral opioid analgesics.