FDA Approves Dyloject Injection for Pain Management

The FDA today approved Hospira Inc’s diclofenac sodium (Dyloject) injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic, for the treatment of mild to moderate pain or for the management of moderate to severe pain alone or in combination with opioid analgesics among adults.

Dyloject will serve as another injectable therapy option that can be administered in a small volume intravenous bolus over 15 seconds; this makes it different from other injectable nonopioid analgesics that are formulated in large volumes and require dilution or a longer infusion time.

In a study of 245 adults with postoperative pain, patients received either Dyloject, a positive NSAID control, or placebo every 6 hours, starting within 6 hours after surgery. While 92% of patients in the placebo group took morphine as a rescue medication for pain in the first 48 hours of treatment, 63% of patients in the Dyloject group took morphine. Patients taking Dyloject showed a greater reduction in pain intensity than patients who received placebo in a 48-hour period.

“In today's health care 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 at

Hospira

, in a press release. “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 nonopioid option that can be administered quickly and conveniently to treat pain.”