A needle-free approach will help control postoperative pain in hospital

FDA has approved the first needle-free, patient-controlled fentanyl delivery system for the management of postoperative pain in adults requiring opioid pain relief in the hospital.

The fentanyl iontophoretic transdermal system (Ionsys, The Medicines Company) has the potential to help more than 8 million U.S. patients annually who need opioid analgesia following in-patient surgery. Every year, approximately 7 million surgical patients are treated with postoperative parenteral opioid therapy and 1.3 million manage postoperative pain with patient-controlled analgesia (PCA), according to Clive Meanwell, MD, PhD, chairman and CEO of The Medicines Company. He spoke on an investor’s conference call on May 5.

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“The reason why there are only 1.3 million patients who manage their pain with intravenous PCA-based on market research of more than 1,000 caregivers, including nurses, doctors, pharmacists-is that it is a difficult setup to do PCA,” Clive said on the conference call. “It requires a lot of work, a lot of steps, and a lot of time. The reason the preferred method of analgesia, PCA, is not fulfilled, is that it is difficult to set up the systems.”

The Ionsys device appears to be easier to use and is not as challenging for caregivers to set up, he noted.

Following surgery, patients who have received the Ionsys device will be able to dispense fentanyl transdermally via an electrical current with a press of a button. This alternative to intravenous patient-controlled analgesia may improve patient mobility, according to Eugene R. Viscusi, MD, professor of anesthesiology and director of Acute Pain Management at Thomas Jefferson University in Philadelphia.

“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,” Viscusi said in a news statement.

“With patient satisfaction increasingly being directly linked to hospital reimbursement, it is critical for hospitals to have effective pain management options available for their post-surgical patients,” Meanwell said in a statement.

The Medicines Company has more than 100 customer service representatives to train U.S. hospital staff in the use of Ionsys. The device will be available in July.

REMS program

The device was approved with a risk evaluation and mitigation strategy (REMS) program because of the potential life-threatening risk of respiratory depression due to accidental exposure. Hospitals will be required to enroll in the REMS program before dispensing Ionsys.

The device is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity to fentanyl or cetylpyridinium or any component of Ionsys.

Possible adverse reactions include headaches, hypotension, nausea, vomiting, anemia, dizziness, application-site erythema, pruritus, and urinary retention, according to the manufacturer.

Treatment with Ionsys is for in-patient hospital use only.