The Medicines Company announces FDA approval of Ionsys (fentanyl iontophoretic transdermal system) for the management of acute post-pperative pain for adult patients in the hospital

FDA

The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.

A recent survey of post-surgical patients indicates that of the more than 51 million in-patient surgeries performed annually in the U.S., approximately 65 percent of post-operative patients experience moderate-to-severe pain. According to an 2012 analysis of the Premier Hospital Database, 1.4 million patients manage their pain with intravenous patient-controlled analgesia (IV-PCA). However, acute post-operative pain continues to be a concern for patients, as 53 percent of patients surveyed in the hospital reported anxiety about their post-operative pain.

Ionsys 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. Ionsys will only be administered to patients in hospitals enrolled in the Ionsys Risk Evaluation 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.

For more details, go to: http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArticle&ID=2042812

Michael Wonder

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Michael Wonder

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