The FDA has approved Hospira, Inc.’s Dyloject (diclofenac sodium) Injection. The proprietary nonsteroidal anti-inflammatory drug (NSAID) is indicated for the treatment of adults with mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics.
“While not a replacement for opioids, Dyloject is [an] 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,” according to a company press release.
Dyloject’s approval is based on two double-blind, placebo and active-controlled, multiple-dose clinical trials in adult patients with postoperative pain. In both trials, IV morphine was permitted as rescue medication for pain management.
In one controlled, multiple-dose study of adult patients with postoperative pain from elective abdominal or pelvic surgery, 245 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine) or a placebo administered every six hours starting within six hours after surgery and for up to five days. Approximately 63% of patients in the Dyloject group and 92% 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 zero to 48 hours in patients receiving Dyloject, compared with placebo.
In a second controlled, multiple-dose study of adult patients with postoperative pain from elective orthopedic surgery, 277 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine) or a placebo administered every six hours starting within six hours after surgery and for up to five days. Approximately 74% of patients in the Dyloject group and 92% 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 zero to 48 hours in patients receiving Dyloject, compared with placebo.
The most common adverse reactions (>5%) to Dyloject in controlled clinical trials include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting and insomnia.
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