FDA Okays Diclofenac Injection (Dyloject) for Pain

Susan Jeffrey

Disclosures

December 30, 2014

The US Food and Drug Administration (FDA) has approved diclofenac sodium injection (Dyloject, Hospira Inc), a proprietary nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain, and for the management of moderate to severe pain alone or in combination with opioids.

"While not a replacement for opioids, Dyloject is another injectable therapy option that can be administered more conveniently in a small volume intravenous bolus over 15 seconds as opposed to other injectable non-opioid 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," notes a statement from the company announcing the FDA approval.

Approval of this formulation was based on two double-blind, placebo-controlled, active comparator trials of adult patients with postoperative pain. In both trials, intravenous morphine was permitted as rescue medication.

In one trial, a controlled, multiple-dose study of adult patients who had undergone elective abdominal or pelvic surgery, 245 patients received injectable diclofenac, a positive NSAID control, ketorolac tromethamine, or placebo, given every 6 hours starting within 6 hours of surgery and continuing for up to 5 days.

Rescue medication was required in approximately 63% of those in the Dyloject group vs 92% of those receiving placebo in 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 company statement notes.

A second similar study in 277 patients undergoing elective orthopedic surgery also compared Dyloject vs ketorolac and placebo given every 6 hours starting within 6 hours after surgery and given up to 5 days. In this study, approximately 74% of those in the Dyloject group and 92% of placebo recipients required rescue medication within the first 48 hours of treatment. Again, 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 compared with placebo, the statement notes.

The company did not provide results of the comparison between diclofenac and ketorolac in their statement, and when approached for comment, a spokesperson for Hospira declined to provide the data to Medscape Medical News or provide a citation where this comparison is published.

The most common adverse reactions (>5%) in controlled trials with the diclofenac injection include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.

The product carries a boxed warning indicating risk for serious cardiovascular events, including myocardial infarction and stroke, which can be fatal and may increase with duration of use, and gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal and can occur at any time without warning symptoms. Elderly patients are at greatest risk for gastrointestinal events.

Dyloject is contraindicated for the management of perioperative pain in the setting of coronary artery bypass graft surgery. It is also contraindicated for patients with a known sensitivity to diclofenac; a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; and moderate to severe renal insufficiency in the perioperative period (such patients are at risk for volume depletion.

Full prescribing information can be found here.

Javelin Pharmaceuticals, a wholly owned subsidiary of Hospira Inc, is the approved license holder of Dyloject.

"In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organizations are now recommending a multimodal approach to pain control in an effort to minimize the use of opioids," said Sumant Ramachandra, MD, PhD, senior vice president and chief scientific officer, Hospira. "As a leading supplier of hospital pain management medication, Hospira's Dyloject 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."  

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