EMA Panel Backs Fentanyl Patch Ionsys for Acute Postop Pain

Megan Brooks


September 25, 2015

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the fentanyl transdermal system Ionsys (The Medicines Company) for short-term management of acute, moderate-to-severe postoperative pain in adults.

Ionsys (3.2 mg/24 hours) "will be the only needle-free, patient-controlled, pre-programmed fentanyl delivery system for use in patients requiring opioid analgesia in EU hospital settings," the company said in a news release.

The efficacy of Ionsys was demonstrated in three placebo-controlled trials, and safety was established in three placebo-controlled trials and four additional active-controlled randomized trials, the company said. The most common adverse effects are nausea, vomiting, and erythema at the application site.

Ionsys should be prescribed by physicians experienced in the management of opioid therapy and is not intended for home use. It should be used only in a hospital setting, the EMA said.

"There is a continuing need for improved treatments and delivery technologies to ensure consistent and predictable pain relief for millions of patients," Loretta Itri, MD, executive vice president, Global Health Science and Regulatory, The Medicines Company, said in a statement. Ionsys transdermal system has the "advantage of no IV [intravenous] lines so that patients can be more mobile during recovery."

The US Food and Drug Administration (FDA) approved the Ionsys fentanyl patch for acute postoperative pain earlier this year.

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, director of acute pain management at Thomas Jefferson University in Philadelphia, Pennsylvania, said at the time of FDA approval in a company news release announcing the approval.

Detailed recommendations for use of Ionsys will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.


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