Non-opioid painkiller gets FDA approval

December 31, 2014

FDA's approval of a new non-opioid painkiller injection expected to help in the fight against prescription painkiller abuse.

FDA's approval of a new non-opioid painkiller injection expected to help in the fight against prescription painkiller abuse.

More than 16,500 deaths related to opioid-prescription drugs were reported in 2010.

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On December 30, FDA approved Hospira’s 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.

"In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organizations are now recommending a multi-modal 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 of Hospira.

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, according to Hospira.

Dyloject's approval is based on two 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.

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In one controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective abdominal or pelvic surgery, 245 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours starting within 6 hours after surgery and for up to 5 days. 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 0 to 48 hours in patients receiving Dyloject as compared to placebo.  

In a second controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective orthopedic surgery, 277 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours starting within 6 hours post-surgery and for up to 5 days.

Approximately 74% 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 0 to 48 hours in patients receiving Dyloject as compared to placebo.

The most common adverse reactions in controlled clinical trials with Dyloject include nausea, constipation, headache, infusion-site pain, dizziness, flatulence, vomiting and insomnia.