LAKE FOREST, Ill., Dec. 30, 2014 /PRNewswire/ -- Hospira,
Inc. (NYSE: HSP), the world's leading provider of injectable
drugs and infusion technologies, and a global leader in
biosimilars, has received approval from the U.S. Food and Drug
Administration (FDA) for Dyloject™ (diclofenac sodium) Injection, a
proprietary nonsteroidal anti-inflammatory drug (NSAID)
analgesic. Dyloject is indicated for use in adults for the
management of mild to moderate pain and for the management of
moderate to severe pain alone or in combination with opioid
analgesics.
"In today's healthcare environment, pain management and patient
satisfaction are important to hospitals. As a result, various
medical organizations are now recommending a multi-modal approach
to pain control in an effort to minimize the use of opioids," said
Sumant Ramachandra, M.D., Ph.D., senior vice president and chief
scientific officer, Hospira. "As a leading supplier of hospital
pain management medication, Hospira's Dyloject will be a
complementary addition to our existing portfolio of acute-care
drugs, providing clinicians an additional non-opioid option that
can be administered quickly and conveniently to treat
pain."
As one of the most commonly used analgesics worldwide, NSAIDs
also have been studied for anti-inflammatory effects. While not a
replacement for opioids, Dyloject is another injectable therapy
option that can be administered more conveniently in a small volume
intravenous bolus over 15 seconds as opposed to other injectable
non-opioid analgesics that are formulated in large volumes or
require dilution prior to administration and typically require an
infusion of 15 to 30 minutes to administer the full dose.
Clinical Trials
During clinical development, 1,156 subjects of both healthy
volunteers and patients were exposed to Dyloject in multiple-dose,
controlled and open-label studies. Dyloject's approval is based on
two double-blind, placebo and active-controlled, multiple-dose
clinical trials of adult patients with postoperative pain. In both
trials, intravenous (I.V.) morphine was permitted as rescue
medication for pain management.
In one controlled, multiple-dose study of adult patients with
postoperative pain who had undergone elective abdominal or pelvic
surgery, 245 patients were treated with Dyloject, a positive NSAID
control (ketorolac tromethamine), or placebo administered every six
hours starting within six hours after surgery and for up to five
days. Approximately 63 percent of patients in the Dyloject group
and 92 percent of patients in the placebo group took rescue
medication within the first 48 hours of the treatment phase.
Efficacy was demonstrated by a reduction in pain intensity as
measured by the sum of the pain intensity differences over 0 to 48
hours in patients receiving Dyloject as compared to placebo.
In a second controlled, multiple-dose study of adult patients
with postoperative pain who had undergone elective orthopedic
surgery, 277 patients were treated with Dyloject, a positive NSAID
control (ketorolac tromethamine), or placebo administered every six
hours starting within six hours post-surgery and for up to five
days. Approximately 74 percent of patients in the Dyloject group
and 92 percent of patients in the placebo group took rescue
medication within the first 48 hours of the treatment phase.
Efficacy was demonstrated by a reduction in pain intensity as
measured by the sum of the pain intensity differences over 0 to 48
hours in patients receiving Dyloject as compared to placebo.
The most common adverse reactions (>5%) in controlled
clinical trials with Dyloject include nausea, constipation,
headache, infusion site pain, dizziness, flatulence, vomiting, and
insomnia.
Indications and Usage
Dyloject is an NSAID indicated in adults for the management of mild
to moderate pain and management of moderate to severe pain alone or
in combination with opioid analgesics.
Important Safety Information
BOXED WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS:
- Cardiovascular Risk
- Non-steroidal anti-inflammatory drugs (NSAIDs) may increase
the risk of serious cardiovascular (CV) thrombotic events,
myocardial infarction, and stroke, which can be fatal. Risk may
increase with duration of use. Patients with cardiovascular disease
or risk factors for cardiovascular disease may be at greater
risk.
- Dyloject is contraindicated for the treatment of
perioperative pain in the setting of coronary artery bypass graft
(CABG) surgery.
- Gastrointestinal Risk
- NSAIDs increase the risk of serious gastrointestinal (GI)
adverse events including bleeding, ulceration, and perforation of
the stomach or intestines, which can be fatal. Events can occur at
any time without warning symptoms. Elderly patients are at greater
risk.
Dyloject is contraindicated in patients with:
- Known hypersensitivity to diclofenac.
- History of asthma, urticaria, or allergic-type reactions after
taking aspirin or other NSAIDs.
- Perioperative pain in the setting of coronary artery bypass
graft (CABG) surgery.
- Moderate to severe renal insufficiency in the perioperative
period and who are at risk for volume depletion.
Dyloject warnings & precautions include:
- Serious and potentially fatal cardiovascular (CV) thrombotic
events, myocardial infarction and stroke: Patients with known CV
disease or risk factors for CV disease may be at greater risk. Use
for the shortest possible duration.
- Serious gastrointestinal (GI) adverse events including
bleeding, ulceration and perforation, which can be fatal: Use for
the shortest possible duration. Use with caution in patients with
prior history of ulcer disease or GI bleeding.
- Renal papillary necrosis and other renal injury with long-term
administration of NSAIDs: Use Dyloject with caution in patients at
greatest risk for this reaction, including the elderly; those with
impaired renal function, heart failure, or liver impairment; and
those taking diuretics or ACE inhibitors.
- Elevation of one or more liver tests and severe hepatic
reactions: Discontinue Dyloject immediately if abnormal liver tests
persist or worsen.
- New onset or worsening of hypertension: Monitor blood pressure
closely during treatment with Dyloject.
- Fluid retention and edema: Use Dyloject with caution in
patients with fluid retention or heart failure.
- Anaphylactic reactions in patients with the aspirin triad or in
patients without prior exposure to Dyloject: Discontinue Dyloject
immediately if an anaphylactic reaction occurs.
- Serious skin reactions such as exfoliative dermatitis,
Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis
(TEN), which can be fatal: Discontinue Dyloject if rash or other
signs of local skin reaction occur.
The most common adverse reactions (>5%) in controlled
clinical trials include nausea, constipation, headache, infusion
site pain, dizziness, flatulence, vomiting, and insomnia.
These highlights do not include all the information needed to
use Dyloject safely and effectively. See full prescribing
information for Dyloject.
Javelin Pharmaceuticals, a wholly-owned subsidiary of
Hospira, Inc., is the approved license holder of
Dyloject.
About Hospira
Hospira, Inc. is the world's leading
provider of injectable drugs and infusion technologies, and a
global leader in biosimilars. Through its broad, integrated
portfolio, Hospira is uniquely positioned to Advance Wellness™ by
improving patient and caregiver safety while reducing healthcare
costs. The company is headquartered in Lake Forest, Ill. Learn more at
www.hospira.com.
-- Private Securities Litigation Reform Act of
1995 --
A Caution Concerning Forward-Looking
Statements
This press release contains, or may contain, 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,
regulatory, post-market study results, legal, technological,
manufacturing, supply, quality and other factors that may affect
Hospira's operations, and may cause actual results to be materially
different from expectations also 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 subsequent Forms 10-Q, filed with the Securities and
Exchange Commission, which are incorporated by reference. Hospira
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments, except as required by law.
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SOURCE Hospira, Inc.