FDA approves Hospira's Dyloject (diclofenac sodium) Injection for pain management

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.