Hospira Inc. 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. The medication is described as another injectable therapy option that can be administered more conveniently in a small volume intravenous bolus over 15 seconds as opposed to other injectable nonopioid 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.
The approval is based on 2 double-blind, placebo and active-controlled, multiple-dose clinical trials of adult patients with postoperative pain. In both trials, IV morphine was permitted as rescue medication for pain management. 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.
Read a press release from Hospira on the approval here.