FDA Approves New Indication for Hospira's Precedex (Dexmedetomidine HCL) Injection
October 30 2008 - 10:30AM
PR Newswire (US)
- Expands Therapy to Broader Patient Population - LAKE FOREST,
Ill., Oct. 30 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE:HSP), 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. About Hospira 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.
http://www.newscom.com/cgi-bin/prnh/20040503/HSPLOGO
http://photoarchive.ap.org/ DATASOURCE: Hospira, Inc. CONTACT:
media, Dan Rosenberg, +1-224-212-3366, or investors, Karen King,
+1-224-212-3323, both of Hospira, Inc. Web site:
http://www.hospira.com/
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