The U.S. Food and Drug Administration (FDA) approved Hospira's Proprietary Analgesic Dyloject (diclofenac sodium) Injection which will be used to treat mild to severe pain in adults.
The drug s a nonsteroidal anti-inflammatory drug (NSAID) analgesic and can be used in combination with opioid analgesics, the drug company Hospira reported.
"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'sDyloject 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."
NSAIDs are one of the most commonly-used painkillers across the globe, and are also known to have ant-inflammatory qualities. Dyloject cannot replace opioids, but is an injectable therapy option that can be administered more conveniently and in smaller doses than other injectable non-opioid analgesics.
In the clinical trials for the newly-approved drugs 1,156 subjects that were both healthy volunteers and patients were exposed to Dyloject in "multiple-dose, controlled and open-label studies." The recent approval was based on two double-blind, placebo and active-controlled, multiple-dose clinical trials.
The first study looked at adult patients with postoperative pain who had undergone elective abdominal or pelvic surgery. The 245 patients were treated with Dyloject, a positive NSAID control , or a placebo. The researchers observed 63 percent of patients in the Dyloject group and 92 percent in the placebo group took rescue medication within the first 48 hours of pain treatment.
In the second study focused on adult patients with postoperative pain who had undergone elective orthopedic surgery. These 277 patients were also treated with either Dyloject, a positive NSAID control, or a placebo. About 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 treatment.
The most common side effects associated with the drug included: "nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia."
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