FDA OKs First Patient-Controlled Patch for Postop Pain

Megan Brooks

May 01, 2015

The US Food and Drug Administration has approved fentanyl iontophoretic transdermal system (Ionsys, The Medicines Co), the first needle-free, patient-controlled, preprogrammed fentanyl delivery system for management of acute postoperative pain in adults requiring opioid analgesia in the hospital, according to a company news release.

Ionsys is a "novel alternative" to traditional intravenous patient-controlled analgesia that uses a "credit-card-sized, self-adherent device employing an imperceptible electric current to deliver on-demand fentanyl," Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University in Philadelphia, Pennsylvania, said in the release.

"Ionsys fits well in a multi-modal analgesic approach allowing opioid administration as a complement to other non-opioid based therapies. The simplicity of this device may make patient mobility and physical therapy easier while reducing the potential burdens associated with a programmable pump," Dr Viscusi added.

"An important concern for nurses treating postoperative patients is the efficiency with which they are able to administer patient-controlled analgesia," Cecile R. Pestano, RN, BSN, CCRP, nurse manager of clinical research, Beaumont Health System, Detroit, Michigan, commented in the release. "Ionsys has the potential to optimize nursing care for postoperative patients, resulting in a high degree of nurse satisfaction, while also improving patient mobility."

The efficacy of Ionsys was established in three placebo-controlled trials, while safety was established in three placebo-controlled trials and four additional active-controlled randomized trials, the company said.

Ionsys is not intended for home use and will only be given to patients in hospitals enrolled in the Ionsys Risk Evaluation Mitigation Strategy (REMS) program. The goal of the Ionsys REMS is to mitigate the risk for respiratory depression resulting from accidental exposure to persons for whom it is not prescribed, the company said.

The company expects Ionsys to be available in the US later this year.

Ionsys was approved in the European Union in 2006.


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