FDA Approves Dyloject for Mild, Severe Pain

Share this content:

the Neurology Advisor take:

The FDA has approved Dyloject (Hospira Inc.), a nonsteroidal diclofenac sodium injection for the treatment of mild to moderate pain and the management of severe pain in conjunction with or without opioids.

The drug is administered in a low volume intravenous bolus over 15 seconds compared to other intravenous non-opioid analgesics that are often formulated in large volumes, require dilution, and are administered over 15 to 30 minutes.

The drug was approved following the results of two double-blind, placebo-controlled trials of adults with postoperative pain. Both trials used intravenous morphine as a rescue medication. In one trial, 63% of patients taking Dyloject required rescue medication compared to 92% of those receiving placebo in the first 48 hours of treatments. In a second study, 74% of patients taking Dyloject required rescue medication compared to 92% of patients receiving ketorolac and placebo. The most common adverse reactions included nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.

Dyloject is also indicated for the management of perioperative pain for coronary artery bypass graft surgery and for patients with sensitivity to diclofenac. The drug does come with a boxed warning for risk of serious cardiovascular and gastrointestinal events, including myocardial infarction, stroke, and intestinal bleeding, which can be fatal.  

Disease-Modifying Relapsing MS Treatments
FDA Approves Dyloject for Mild, Severe Pain

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.

READ FULL ARTICLE From Med Scape
You must be a registered member of Neurology Advisor to post a comment.

Sign Up for Free e-newsletters

CME Focus