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DAR No 12. Sublingual fentanyl citrate (Abstral®) For breakthrough pain in cancer patients

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Another formulation in a perilous and lucrative oral fentanyl market

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  • Sublingual fentanyl is indicated solely for breakthrough pain in cancer patients, whenever pain is characterized by persistence in time, and patients are already under management with chronic opioid agents.
  • The evidence of sublingual fentanyl efficacy is scarce, with only one study available comparing it to placebo. There are no comparative studies with different formulations of fentanyl available on the market, or any of the other immediate release opioids.
  • This potent opioid is not safer than other opiods and bears a similar adverse reaction profile to the other opioids.
  • It requires an adjustment and titration phase to establish the effective dose for each patient. Interchanges of the different formulations of oral fentanyl at the same doses is not possible as they are not equivalent.
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