Dyloject approved by FDA for Pain-Hospira

Hospira has received approval from the FDA for Dyloject (diclofenac sodium) injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic 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. Dyloject's approval is based on two trials of patients with postoperative Pain. In both trials, intravenous (I.V.) morphine was permitted as rescue medication for pain management. In one study 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 study 277 patients were treated with Dyloject, and 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.