Hospira announced it has received approval from the Food and Drug Administration (FDA) for Dyloject (diclofenac sodium) Injection for the management of mild to moderate pain in adults, and for moderate to severe pain alone or in combination with opioid analgesics.
Dyloject offers a more convenient administration as a small volume IV bolus compared with other non-opioid injectables that are formulated in large volumes or require dilution, typically requiring 15-30 minutes to administer the full dose. Dyloject is a non-steroidal anti-inflammatory (NSAID) drug that exhibits anti-inflammatory analgesic and antipyretic activities. It is thought to involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways, and inhibition of prostaglandin synthetase.
The FDA approval was based on two double-blind, placebo, and active-controlled, multiple-dose clinical trials of adults with postoperative pain. Intravenous (IV) morphine was allowed as rescue medication for pain in both studies.
In one study (n=245), patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo every six hours starting within six hours after surgery and for up to five days. About 63% of patients in the Dyloject group and 92% in the placebo group took rescue medication within the first 48 hours of the treatment phase. In the second study (n=277), 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.
Dyloject will be available as a 37.5mg/mL strength vials in 25-count cartons.
For more information call (800) 441-4100 or visit Hospira.com.