Introduction: Breakthrough pain is an important consideration in the care of cancer patients. It consists of a transient worsening of pain occurring spontaneously or related to some predictable or non-predictable triggering factor, in a patient with relatively stable and adequately controlled basal pain. Objective: The primary objective of this study is to show the relationship between the pharmacokinetic characteristics of fentanyl pectin nasal spray and its efficacy and safety in application to breakthrough pain. Method: The pharmacokinetic characteristics of fentanyl pectin nasal spray were compared with those of other formulations of fentanyl - an opioid with potent analgesic action indicated for the treatment of breakthrough pain. In addition, a comment is made of the results of different clinical studies addressing efficacy, safety, and convenience of use of the drug. Results: Fentanyl pectin nasal spray was found to be the safest formulation, with a lower incidence of local side effects and better tolerability compared with other intranasal formulations (chitosan and chitosan-poloxamer). Its pharmacokinetic characteristics allow better treatment of cancer breakthrough pain thanks to the rapid absorption and onset of action of the drug, significant reduction of the Cmax values with the maintenance of therapeutically effective concentrations, proportionality between fentanyl exposure and dose (range 100-800 µg), and very good acceptance of this formulation by the patients. Conclusion: Fentanyl pectin nasal spray offers an effective and innovative solution for the treatment of breakthrough pain, with added value in patients with dry mouth
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