The drive to improve the treatment of postoperative pain has led to the development of patient-controlled analgesia (PCA), particularly using the intravenous (IV) route, has resulted in marked improvements in the management of acute postoperative pain. PCA allows patients to self-administer analgesics according to their personal requirements for pain relief by activating a button connected to an infusion pump which delivers a prescribed amount of narcotic. Consequently, patients can maintain a uniform level of analgesia and avoid potentially long delays in the administration of analgesics by busy hospital personnel. Furthermore, patient can avoid the delivery of more narcotics than needed, which may result in a variety of unwanted side-effects including respiratory depression, nausea, vomiting, constipation, itching, and others.
Although it is estimated that approximately 50% of patients receive IV PCA after surgery, IV PCA has been associated with programming, medication, and pump errors, IV line infections and occlusions, phlebitis, needlestick injuries, analgesic gaps, limited patient mobility, and significant hospital financial and staff resources.
IONSYS™ (fentanyl iontophoretic transdermal system) is an investigational product candidate intended to provide patient-controlled analgesia for adult inpatients requiring opioids following surgery. IONSYS is a compact, needle-free, self-contained, pre-programmed system designed to be applied to the skin on the upper arm or chest and activated by patients double clicking a button on the system. A generally imperceptible electrical current then actively delivers a small dose of the short-acting opioid analgesic fentanyl directly through the skin and into the systemic circulation.
IONSYS™ was approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2006; however, IONSYS™ is not currently marketed anywhere in the world. Before marketing IONSYS, regulatory approval must be sought from both the FDA and EMA for new features being developed into the system.