Effects of fentanyl nasal spray: A Synthesis of Findings from 13 Studies

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Original Abstract of the Article

Major Research Findings

Fentanyl nasal spray has been shown to be effective for the treatment of breakthrough pain in opioid-tolerant cancer patients. 8 , 7 , 5 . Fentanyl nasal spray acts faster than morphine and is more suitable for alleviating breakthrough pain. 7 . Fentanyl nasal spray also uses a pectin-based drug delivery system to optimize absorption and suppress peak plasma concentrations. 10 . In addition, fentanyl nasal spray can be used to treat breakthrough pain in children and young people. 11 . However, fentanyl nasal spray can cause metabolic toxicity such as hyperglycemia and hypercholesterolemia. 2 . Everolimus, an mTOR inhibitor used in cancer treatment, is known to cause metabolic toxicity. 3 .

Benefits and Risks

Benefit Summary

Fentanyl nasal spray has been shown to be effective in treating breakthrough pain. Fentanyl nasal spray works faster than morphine and is more suitable for relieving breakthrough pain. Fentanyl nasal spray can also be used to treat breakthrough pain in children and young people.

Risk Summary

Fentanyl nasal spray may cause metabolic toxicity such as hyperglycemia and hypercholesterolemia.

Comparison of Studies

Commonalities in Studies

All of these studies have shown that fentanyl nasal spray is effective in treating breakthrough pain. All of these studies have also evaluated the safety and tolerability of fentanyl nasal spray.

Differences in Studies

These studies differ in the subjects, dosages, and evaluation methods used for fentanyl nasal spray. For example, 8 included opioid-tolerant cancer patients. 7 evaluated the effectiveness of fentanyl nasal spray compared to morphine. 11 included children and young people.

Consistency and Contradictions of Results

The results of these studies are consistent, showing that fentanyl nasal spray is effective in treating breakthrough pain. However, further research is needed on the metabolic toxicity of fentanyl nasal spray.

Cautions for Practical Applications

It is important to use fentanyl nasal spray according to the doctor's instructions. It is dangerous to take it on your own judgment. Also, fentanyl nasal spray may cause metabolic toxicity such as hyperglycemia and hypercholesterolemia. Be aware of these side effects and consult your doctor if necessary.

Limitations of Current Research

All of these studies are relatively small and further research is needed. Also, all of these studies have focused on specific types of cancer patients, and further research is needed to apply them to other types of patients.

Future Research Directions

Future research is needed on the metabolic toxicity of fentanyl nasal spray, the application to other types of patients, and the long-term safety and effectiveness.

Conclusion

Fentanyl nasal spray has been shown to be effective in treating breakthrough pain. However, it may cause metabolic toxicity such as hyperglycemia and hypercholesterolemia. Use according to your doctor's instructions and be aware of side effects.

Literature analysis of 13 papers
Positive Content
12
Neutral Content
0
Negative Content
1
Article Type
4
2
1
2
13
1.

Phase 1 and pharmacodynamic trial of everolimus in combination with cetuximab in patients with advanced cancer.

Author: CiunciChristine A, PeriniRodolfo F, AvadhaniAnjali N, KangHyunseon C, SunWeijing, RedlingerMaryann, HarlackerKathleen, FlahertyKeith T, GiantonioBruce J, RosenMark A, DivgiChaitanya R, SongHee Kwon, EnglanderSarah, TroxelAndrea, SchnallMitchell, O'DwyerPeter J

Disease control
Mucositis
Skin toxicity

Everolimus and cetuximab can be safely administered together at standard doses and are associated with prolonged disease control. The recommended dose for Phase 2 trials is 70 mg of oral everolimus weekly in combination with standard cetuximab. Imaging studies indicate that metabolic inhibition by everolimus alone and in combination with cetuximab predominates over changes in tumor perfusion in this patient population.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Relationship between metabolic toxicity and efficacy of everolimus in patients with neuroendocrine tumors: A pooled analysis from the randomized, phase 3 RADIANT-3 and RADIANT-4 trials.

Author: FazioNicola, CarnaghiCarlo, BuzzoniRoberto, ValleJuan W, HerbstFabian, RidolfiAntonia, StrosbergJonathan, KulkeMatthew H, PavelMarianne E, YaoJames C

Tumor treatment
Hypercholesterolemia
Hyperglycemia

Hyperglycemia and hypercholesterolemia did not have a significant impact on PFS in patients treated with everolimus.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Everolimus therapy and side‑effects: A systematic review and meta‑analysis.

Author: ArenaClaudia, BizzocaMaria Eleonora, CaponioVito Carlo Alberto, TroianoGiuseppe, ZhurakivskaKhrystyna, LeuciStefania, Lo MuzioLorenzo

Cancer treatment
Adverse events

This systematic review aimed to evaluate the type and incidence of side effects in patients treated with everolimus. The primary adverse events reported were stomatitis, leukopenia, anorexia, anemia, and fatigue, with the majority of patients experiencing grade 1 or 2 adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

5.

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

Author: DietrichEric, GumsJohn G

Faster pain relief
Less nausea/vomiting
High cost

Intranasal fentanyl spray is effective for breakthrough cancer pain in adults receiving stable opioid therapy, with a faster onset of action than oral therapies. The most common side effects include nausea, vomiting, vertigo, and dizziness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Efficacy and safety of fentanyl pectin nasal spray compared with immediate-release morphine sulfate tablets in the treatment of breakthrough cancer pain: a multicenter, randomized, controlled, double-blind, double-dummy multiple-crossover study.

Author: FallonMarie, RealeCarlo, DaviesAndrew, LuxA Eberhard, KumarKirushna, StachowiakAndrzej, GalvezRafael,

Faster pain relief
Well tolerated
No significant nasal effects

Fentanyl pectin nasal spray (FPNS) was efficacious and well tolerated in the treatment of breakthrough cancer pain (BTCP) and provided faster onset of analgesia and attainment of clinically meaningful pain relief (CMPR) than immediate-release morphine sulfate (IRMS).

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients.

Author: PortenoyRussell K, RaffaeliWilliam, TorresLuis M, SitteThomas, DekaAkhil Chandra, HerreraIleana Gonzalez, WallaceMark S,

Reduced BTCP
Opioid side effects

Fentanyl pectin nasal spray (FPNS) effectively treats breakthrough cancer pain, with a high proportion of episodes resolved with a single dose. It is generally well-tolerated with no evidence of nasal toxicity.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Pharmacokinetic comparisons of three nasal fentanyl formulations; pectin, chitosan and chitosan-poloxamer 188.

Author: FisherA, WatlingM, SmithA, KnightA

Optimized absorption
Reduced C(max)

This study evaluated the venous pharmacokinetic profiles and tolerability of three new fentanyl nasal spray formulations (FPNS, FChNS, and FChPNS) compared to an oral transmucosal fentanyl citrate (OTFC) lozenge. The aim was to optimize the absorption profile and reduce peak concentration (Cmax) of fentanyl.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

PecSys: in situ gelling system for optimised nasal drug delivery.

Author: WattsPeter, SmithAlan

Convenient dosing
Pain relief

PecSys (PS), a pectin-based drug delivery system, shows promise for intranasal drug delivery, particularly for opioid analgesics. A fentanyl nasal spray formulation (NasalFent) using PS has successfully met its primary objective in a Phase III clinical study and is scheduled for regulatory filings.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

The use of rapid onset fentanyl in children and young people for breakthrough cancer pain.

Author: CoombesLucy, BurkeKimberley, AndersonAnna-Karenia

Fentanyl dosing
Side effects

This study examined the use of rapid-onset fentanyl in children. It found no correlation between the effective dose of fentanyl and the child's age, weight, or the amount of morphine they were already taking. The study also reviewed the side effects of fentanyl in children.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

12.

Pharmacokinetics, analgesic effect, and tolerability of a single preprocedural dose of intranasal fentanyl in patients undergoing drain removal after breast reduction or augmentation surgery: A prospective, randomized, double-blind, placebo-controlled study.

Author: Veldhorst-JanssenNicole M L, FiddelersAudrey A A, van der KuyPaul-Hugo M, KesselsAlfons G H, TheunissenH Maurice S, van der HulstRené R W J, NeefCees, MarcusMarco A E

Pain control

This abstract describes the potential use of intranasally administered fentanyl for pain control during surgical drain removal after breast reduction or augmentation surgery. The authors suggest that fentanyl may be suitable due to its reported therapeutic window of 0.2-1.2 ng/mL.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

[Serotoninergic antidepressants and opiate analgesics: a sometimes-painful association. A case report].

Author: ReichM, Lefebvre-KuntzD

Serotonin syndrome

This case report describes a patient who developed serotonin syndrome due to drug interactions between nasal fentanyl, oxycodone, and escitalopram. The report highlights the importance of being aware of potential drug interactions and the need for careful monitoring of patients on multiple medications.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

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