FDA Approves New Indication for Hospira’s Precedex (Dexmedetomidine HCL) Injection
LAKE FOREST, Ill., Oct. 30 /PRNewswire-FirstCall/ — Hospira, Inc. , a global specialty pharmaceutical and medication delivery company, announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Precedex(R), 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, M.D., vice chairman of Clinical Research for the Department of Anesthesiology at the University of Miami School of Medicine. “Anesthesiologists 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 orthopedic, 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 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.
“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,” said Paula Bokesch, M.D., global medical director, Global Medical Affairs — Drug Development. “As a practicing anesthesiologist, I know the anesthesiology 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.
Indications and Safety Information
Precedex (dexmedetomidine hydrochloride) is Hospira’s proprietary I.V. sedative, and it is a relatively selective alpha-2-adrenoceptor agonist. In the United States, it is the only drug in its class (alpha-2-agonists) approved for continuous I.V. sedation of initially intubated and mechanically ventilated patients in the intensive-care setting for use up to 24 hours. It can be used before, during and after extubation.
Due to the known pharmacological effects, patients should be continuously monitored while receiving Precedex. Precedex should only be administered by persons skilled in the management of patients in the intensive care or operating room setting. Clinically significant bradycardia and sinus arrest episodes in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration have been reported. Hypotension and/or bradycardia may be more pronounced in hypovolemic patients and in patients with diabetes mellitus, chronic hypertension, and the elderly. Transient hypertension has been observed primarily during the loading dose. The most common treatment-emergent adverse reactions occurring in greater than 2 percent of patients in both intensive care unit and procedural sedation include hypotension, bradycardia, and dry mouth.
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM). As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has more than 14,000 employees. Learn more at http://www.hospira.com/.
Private Securities Litigation Reform Act of 1995 -- A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K, and Hospira’s subsequent Quarterly Reports on Form 10-Q, which are filed with the Securities and Exchange Commission, and incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
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