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Pain-Drug Device Wins Approval for Hospital Use

Launch expected in third quarter of 2015

The FDA has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, preprogrammed fentanyl delivery system, for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital.

According to its manufacturer (The Medicines Group), the device offers patients recovering from surgery in the hospital control over their analgesic dosing by pushing a button to dispense fentanyl transdermally via an imperceptible electrical current as needed for pain. The device is to be used only for hospitalized patients enrolled in the Ionsys risk evaluation and mitigation strategy (REMS) program and is not intended for home use. The goal of the Ionsys REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.

A recent survey of postsurgical patients indicates that of the more than 51 million in-patient surgeries performed annually in the U.S., approximately 65% of postoperative patients experience moderate-to-severe pain. According to a 2012 analysis of the Premier Hospital Database, 1.4 million patients managed their pain with intravenous patient-controlled analgesia. However, acute postoperative pain continues to be a concern, as 53% of patients surveyed in the hospital reported anxiety about their postoperative pain.

Ionsys was originally developed by Johnson & Johnson and won FDA approval in 2006. But after its launch in Europe in 2008, it was recalled because of device stability issues. The Ionsys device never made it to the U.S. market.

The Medicines Company gained access to the treatment through its 2012 acquisition of Incline Therapeutics Inc., which had acquired the device from J&J in 2010.

The new approval puts Ionsys ahead of a rival pain-drug device, Zalviso (AcelRx Pharmaceuticals), which is in phase III development. Zalviso was dealt another blow in March after the FDA said it required an additional study to evaluate risks associated with the device.

The Ionsys device is expected to be available in the U.S. in the third quarter of 2015.

Sources: The Medicines Company; April 29, 2015; and Reuters; April 30, 2015.

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