Patient-controlled pain drug device approved by FDA

Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing. Ionsys (fentanyl iontophoretic transdermal system) from The Medicines Company has just been approved by FDA for this use.

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The pain drug device is the first needleless, patient-controlled, preprogrammed, opioid-based treatment available for the short-term management of acute postoperative pain in hospitalized adults needing opioid analgesia. Postsurgical patients recovering in the hospital can control their analgesic dosing by pushing a button as needed to deliver fentanyl transdermally via an imperceptible electrical current.

According to Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, Philadelphia, the new pain drug device “fits well in a multimodal analgesic approach allowing opioid administration as a complement to other nonopioid based therapies.” Dr Viscusi further explains that “The simplicity of this device may make patient mobility and physical therapy easier while reducing the potential burdens associated with a programmable pump.”

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FDA based its approval on 3 placebo-controlled trials establishing the device’s efficacy and safety. Product safety was also further established by another 4 active-controlled randomized trials.

For hospitalized patients to use this pain drug device, they will need to be enrolled in its Risk Evaluation Mitigation Strategy (REMS) program. The REMS serves the purpose of mitigating the risk for respiratory depression that could result from accidental exposure to others in whom it has not been prescribed.

The fentanyl iontophoretic transdermal system is not intended for home use.

The manufacturer anticipates its availability in the United States in the third quarter of 2015. It is already being used in Europe, having been approved there in 2006.

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