Hospira, Inc, a global specialty pharmaceutical and medication delivery company, announced that the US Food and Drug Administration (FDA) approved a new indication for Precedex, the company's innovative drug for in-hospital sedation. This approval allows for use of Precedex in non-intubated patients requiring sedation prior to and/or during surgical and other procedures. The additional indication complements Precedex's initial approval for the sedation of intubated and mechanically ventilated patients in the intensive care setting for up to
24 hours.
"This expanded indication makes Precedex a more versatile product," said Keith Candiotti, vice chairman of Clinical Research for the Department of Anaesthesiology at the University of Miami School of Medicine. "Anaesthesiologists now have the data to safely administer Precedex in an operating room setting for a number of outpatient procedures that are growing in volume such as orthopaedic, vascular and ophthalmic procedures."
The FDA approval is based on the results of two randomized, prospective, double-blind, multicenter clinical studies - the MAC and AWAKE trials - which, collectively, looked at 431 patients. The MAC study examined patients that underwent a variety of surgical or diagnostic procedures including orthopaedic, vascular, ophthalmic, excision of lesions, breast biopsies and plastic surgery. The AWAKE trial included patients requiring an awake fiberoptic intubation, a specialized anaesthesiology technique to facilitate insertion of an endotracheal tube through the nose or mouth for general anaesthesia in patients with known or suspected difficult airways.
"Hospira is excited to be able to provide Precedex to anaesthesiologists as an alternative agent that can be used for non-intubated patients undergoing surgical and other procedures requiring MAC, or monitored anaesthesia care, as well as those undergoing awake fiberoptic intubation," said Paula Bokesch, global medical director, Global Medical Affairs - Drug Development. "As a practicing anaesthesiologist, I know the anaesthesiology community is going to be eager to use Precedex in this new indication."
This represents the approval of the first of two new supplemental New Drug Applications (sNDA) that have been filed for Precedex in the past 12 months. The second sNDA, which was submitted to the FDA in 2008, evaluated the long term safety and efficacy of Precedex in mechanically ventilated patients in an intensive care setting.