Hospira, a provider of infusion technologies, injectable drugs and biosimilars, announced on Dec. 30 that it has received approval from the U.S. Food and Drug Administration for its proprietary nonsteroidal anti-inflammatory analgesic injectable Dyloject (diclofenac sodium).
As a commonly used analgesic, NSAIDs have been shown to have anti-inflammatory effects. Though not exactly a replacement for opioids, Hospira's Dyloject is an injectable treatment option that is more convenient to administer. It can be given in small amounts intravenously for 15 seconds compared to the usual setup with other non-opioid analgesic injectables where large doses or dilution may be required prior to administration.
"In today's healthcare environment, pain management and patient satisfaction are important to hospitals," said Sumant Ramachandra, M.D., Ph.D., chief scientific officer and senior vice president for Hospira, leading to an adoption of multi-modal approaches in controlling pain while minimizing opioid use.
Ramachandra also added that Dyloject will be introduced as a complement to existing drugs for acute care to provide an additional non-opioid treatment option for pain.
The injectable's approval was based on results from two controlled studies, both of which involved the use of Dyloject, placebo and ketorolac thromethamine, a positive NSAID control. The studies involved 1,156 healthy volunteers and patients, all of which were given doses of the painkiller multiple times.
Patients dealing with post-operative pain after undergoing pelvic or abdominal surgery were included in the first study while the second study enlisted those with post-operative pain due to elective orthopedic surgery. Both studies administered Dyloject, the placebo or ketorolac tromethamine every six hours to patients beginning within the first six hours of them coming out of surgery and lasting up to five days.
For the first study, 63 percent of patients given Dyloject and 92 percent of those in the placebo group were given rescue medication within the first two days of the treatment.
For the second study, 74 percent of patients in the Dyloject group and 92 percent of those given placebo were provided rescue medication within the first two days of the treatment.
Efficacy was measured according to a reduction in the level of pain intensity as shown by the difference in overall pain that patients felt while given Dyloject or a placebo.
Dyloject's approval comes just in time as efforts are increasing toward curbing prescription opioid abuse. While opioids are effective at relieving pain, they can be addicting, leading to overdoses and, in the severest of cases, death. Opioids include morphine, codeine, oxycodone and hydrocodone. The FDA also approved abuse-resistant narcotic painkillers back in November.