The Medical Letter on Drugs and Therapeutics
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1390
Fentanyl Sublingual Spray (Subsys) for Breakthrough Cancer Pain
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The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid therapy (taking ≥60 mg/day of oral morphine or the equivalent). Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and transmucosal use.1,2

PHARMACOKINETICS — An unpublished study (summarized in the package insert) compared a single 400-mcg dose of fentanyl sublingual spray with the same dose of oral transmucosal fentanyl citrate (OTFC) in healthy adults. Median time to peak serum concentration (Tmax) was 1.5 hours with Subsys and 2.0 hours with OTFC; the peak serum concentration (Cmax) and area under the time-concentration curve (AUC) of the spray were 34% and 38% higher, respectively, than those of ... more      

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Title: Fentanyl Sublingual Spray (Subsys) for Breakthrough Cancer Pain
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