FDA Approves Dyloject
Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection
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.
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.
SOURCE Hospira, Inc.
Posted: December 2014
Related articles
- Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA - February 17, 2010
- FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review - February 2, 2010
- Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults - December 2, 2009
Dyloject (diclofenac sodium) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
