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The Medicines Company (NASDAQ:MDCO) has today announced the FDA’s approval of IONSYS® (fentanyl iontophoretic transdermal system).
IONSYS is the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term control of acute post-operative pain in adult patients who need opioid analgesia in the hospital.
A recent survey of post-surgical patients suggests that of the more than 51 million inpatient surgeries performed annually in the U.S., approximately 65 percent of post-operative patients experience moderate-to-severe pain.
According to a 2012 analysis of the Premier Hospital Database, 1.4 million patients handle their pain with the help of intravenous patient-controlled analgesia (IV-PCA).
However, acute post-operative pain is still a concern for patients, as 53 percent of patients studied in the hospital reported anxiety about their post-operative pain.
IONSYS provides patients recovering from surgery in the hospital with control over their analgesic dosing. They push a button to dispense fentanyl transdermally via an undetectable electrical current as needed for pain.
IONSYS is only available for administration to patients in hospitals enrolled in the IONSYS Risk Evaluation Mitigation Strategy (REMS) program and is not intended for home use.
The IONSYS REMS’s goal is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.
Eugene R. Viscusi, MD, Professor of Anesthesiology and Director, Acute Pain Management at Thomas Jefferson University in Philadelphia, viewed IONSYS as a novel alternative to traditional IV-PCA providing needle-free delivery of opioid analgesia with a credit-card-sized, self-adherent device employing an imperceptible electric current to deliver on-demand fentanyl.
He added that IONSYS fits well in a multimodal analgesic approach, which allows opioid administration to complement other non-opioid based therapies.
The simplicity of this device may ease patient mobility and physical therapy further while mitigating the potential burdens associated with a programmable pump.
According to a survey presented at an American Society of Peri Anesthesia Nurses (ASPAN) conference, involving 351 nurses and 507 patients, 63 percent of nurses and 56 percent of patients said that the lack of mobility is a drawback of IV-PCA.
Of the nurses surveyed, 84 percent said that having the option of a needle-free post-operative pain management system would improve their ability to take care of their patients.
According to Cecile R. Pestano, R.N., BSN, CCRP, Nurse Manager, Clinical Research, Beaumont Health System, an essential concern for nurses treating post-operative patients is the efficiency they can administer patient-controlled analgesia.
She added that IONSYS has the potential to optimize nursing care for post-operative patients, resulting in a high degree of nurse satisfaction and improving patient mobility.
Clive Meanwell, MD, Ph.D., Chairman and Chief Executive Officer of The Medicines Company, stated that IONSYS represents an innovative treatment and potential cornerstone in the management of patients with acute post-operative surgical pain.
He spoke for the company, saying that they believe IONSYS is poised to change the management of pain in the hospital.
Patient satisfaction is frequently directly linked to hospital reimbursement; therefore, hospitals must have quality pain management options ready for their post-surgical patients.
“This latest approval serves as a key part of our company’s purpose, which is to contribute to the economic efficiencies of healthcare by providing value-based therapies to hospitals,” he added.
The Medicines Company expects IONSYS to be available in the U.S. in Q3 2015.
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