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FDA Approves Analgesic Dyloject (Diclofenac) Injection

Product offers small-volume IV bolus administration over 15 seconds

The FDA has given the green light to Dyloject (diclofenac sodium) injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. The product 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.

As one of the most commonly used analgesics worldwide, NSAIDs also have been studied for their anti-inflammatory effects. According to the product’s manufacturer (Hospira, Inc.), Dyloject, while not a replacement for opioids, is another injectable therapy option that can be administered in a small-volume intravenous (IV) bolus over 15 seconds as opposed to other injectable non-opioid analgesics, which are formulated in large volumes or require dilution before administration and typically require an infusion of 15 to 30 minutes to administer the full dose.

During the product’s clinical development, a total of 1,156 subjects (both healthy volunteers and patients) were exposed to Dyloject in multiple-dose, controlled, open-label studies. The product’s approval was based on two double-blind, placebo- and active-controlled, multiple-dose clinical studies of adult patients with postoperative pain. In both trials, IV morphine was permitted as a rescue medication for pain management.

In one controlled, multiple-dose study, 245 adult patients with postoperative pain who had undergone elective abdominal or pelvic surgery were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours for up to 5 days, starting within 6 hours after surgery. 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 48 hours in patients treated with Dyloject compared with placebo.

In a second controlled, multiple-dose study, 277 adult patients with postoperative pain who had undergone elective orthopedic surgery were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours for up to 5 days, starting within 6 hours after surgery. Approximately 74% of the Dyloject group and 92% of 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 48 hours in patients receiving Dyloject compared with those given placebo.

The most common adverse reactions observed in clinical trials of Dyloject included nausea, constipation, headache, infusion-site pain, dizziness, flatulence, vomiting, and insomnia.

The labeling for Dyloject includes a boxed warning regarding the potential for serious cardiovascular and gastrointestinal (GI) adverse events.

NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. The risk may increase with the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

NSAIDs also increase the risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Events can occur at any time without warning symptoms. Elderly patients are at greater risk.

Dyloject is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.

Source: Hospira, Inc.; December 30, 2014.

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