Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US.
COMBOGESIC® IV is an intravenous, opioid-free pain relief medicine that is a combination of 1,000 mg of acetaminophen and 300 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). It was approved by the US FDA in October 2023 for use in adults where an intravenous route of administration is considered clinically necessary for: (i) the relief of mild to moderate pain; and (ii) the management of moderate to severe pain as an adjunct to opioid analgesics.
The American Society of Anesthesiology's (ASA) evidence-based recommendations emphasize the importance of a multimodal approach to pain management using multiple interventions with different mechanisms of action that may offer additive or synergistic effects to optimize pain relief.
COMBOGESIC® IV offers health care providers a new, non-opioid approach to pain management by combining active drug substances with different mechanisms of action in a single formulation, providing:
- Shorter onset to analgesia
- Superior analgesia efficacy and comparable safety in common adverse events
- Sustained pain-management results
In a Phase 3 clinical trial, COMBOGESIC® IV provided more than double the pain relief than that of acetaminophen IV and ibuprofen IV alone. Time to meaningful pain relief was shorter in the COMBOGESIC® IV group than that in the Ibuprofen IV or placebo groups. COMBOGESIC® IV also allows for superior analgesia efficacy.
"The approval of COMBOGESIC® IV is an important step in providing hospitals and health care providers in the US with an alternative treatment option for managing patients' pain," said Dr. Bill Larkins, President of Injectables, Hikma. "This is another example of how we continue to expand our portfolio of critical medicines and we are pleased to make this important new treatment option available for patients, helping to put better health within reach, every day."
In 2021, Hikma signed an exclusive license and distribution agreement with AFT Pharmaceuticals (AFT) for the commercialization of COMBOGESIC® IV in the US. Under the trade name of MAXIGESIC® IV outside of the United States, COMBOGESIC® IV is licensed in over 100 countries and marketed in over 20 countries.
About COMBOGESIC® IV
COMBOGESIC® IV is the only IV analgesic therapy formulated with 1,000 mg of acetaminophen and 300 mg of ibuprofen, utilizing the synergistic effect of both medicines for optimal pain relief.1 It offers health care providers a new approach to multimodal analgesia by combining active drug substances with different mechanisms of action that harness additive or synergistic effects to provide more effective pain relief compared with individual components used as single-modality interventions. COMBOGESIC® IV is supplied as a readily available solution with no mixing required for administration. It is administered as a 15-minute IV infusion, every 6 hours as needed, not to exceed the maximum total daily dose of 4,000 mg acetaminophen and 1,200 mg of ibuprofen in 24 hours.
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