The U.S. Food and Drug Administration has approved a new faster acting injectable drug to treat moderate to severe pain.
The diclofenac sodium solution, produced by Hospira Inc. under the brand name Dyloject, is a non-steroidal anti-inflammatory drug (NSAID) that can be used alone or in combination with opioid pain relievers. Hospira (NYSE: HSP) says Dyloject can be administered in 15 seconds, in contrast to other injectable non-opioid painkillers which can take as long as 30 minutes to administer intravenously in a full dose.
Dyloject is most likely to be used in a hospital setting for postoperative pain. It was approved for use by adults in the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioids.
“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, senior vice president and chief scientific officer for 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.”
Dyloject was approved after two double-blind, placebo-controlled studies of adult patients with postoperative pain after abdominal or pelvic surgery. In both trials, intravenous morphine was permitted as rescue medication in case pain relief wasn’t sufficient with Dyloject alone.
In one study, about 63% of patients taking Dyloject took rescue medication with 48 hours of treatment, compared to 92% of patients given a placebo. Similar results were found in a second study.
The most common side effects with Dyloject were nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia. As with other NSAIDs, Dyloject is not recommended for patients with a history of cardiovascular or gastrointestinal problems.