Ionsys (Fentanyl Hydrochloride Transdermal) - Summary

IONSYS SUMMARY

IONSYS™ (fentanyl iontophoretic transdermal system)
40 mcg*/activation

IONSYS™ (fentanyl iontophoretic transdermal system) is a patient-controlled iontophoretic transdermal system providing on-demand systemic delivery of fentanyl, an opioid agonist, for up to 24 hours or a maximum of 80 doses, whichever comes first.

IONSYS™ is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with IONSYS™. IONSYS™ is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS).

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NEWS HIGHLIGHTS

Published Studies Related to Ionsys (Fentanyl Transdermal)

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study. [2011.05]
PURPOSE: The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management... CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.

Pharmacokinetic/pharmacodynamic relationships of transdermal buprenorphine and fentanyl in experimental human pain models. [2011.04]
Pharmacokinetic/pharmacodynamic (PK/PD) modelling can be used to characterize the relationship between dose regimen of opioids, plasma concentration and effect of opioids, which in turn can lead to more rational treatment regimens of pain. The aim of this study was to investigate the concentration-effect relationship for transdermal buprenorphine and fentanyl in experimentally induced pain...

Bioequivalence and safety of a novel fentanyl transdermal matrix system compared with a transdermal reservoir system. [2011.03]
CONCLUSIONS: The transdermal fentanyl matrix system adhered well, was well tolerated, and produced systemic exposures of fentanyl that were bioequivalent to the reservoir system.

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study. [2011]
and efficacy of a 12-h method to a 6-h method in chronic cancer pain management... CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the

The post-operative analgesic effects of epidurally administered morphine and transdermal fentanyl patch after ovariohysterectomy in dogs. [2010.11]
OBJECTIVE: To investigate the analgesic and side effects of epidural morphine or a fentanyl patch after ovariohysterectomy in dogs... CONCLUSION AND CLINICAL RELEVANCE: Epidurally administered morphine provided better analgesia and caused fewer adverse effects than the fentanyl patch after ovariohysterectomy in dogs.

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Clinical Trials Related to Ionsys (Fentanyl Transdermal)

Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery [Terminated]
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery [Terminated]
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.

Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients [Recruiting]
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009). Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.

Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain [Recruiting]
This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy. Secondary quantitative sensory testing is performed to determine thermal and electrical detection and pain threshold and the difference in pain variability scoring. Postoperative pain scores, analgesic use, genetic variances and costs are measured.

A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain [Terminated]

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