Hospira, a specialty pharmaceutical and medication delivery company, has announced that the FDA has 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 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, the company said.
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 orthopedic, vascular, ophthalmic, excision of lesions, breast biopsies and plastic surgery.
The Awake trial included patients requiring an awake fiberoptic intubation, a specialized anesthesiology technique to facilitate insertion of an endotracheal tube through the nose or mouth for general anesthesia in patients with known or suspected difficult airways.
Paula Bokesch, medical director of global medical affairs, drug development at Hospira, said: “Hospira is excited to be able to provide Precedex to anesthesiologists as an alternative agent that can be used for non-intubated patients undergoing surgical and other procedures requiring MAC, or monitored anesthesia care, as well as those undergoing awake fiberoptic intubation.”