A compound injection of acetaminophen plus ibuprofen recently received regulatory approval in Korea on Monday, marking the first landing of a unique double-action formulation for fast and effective pain relief.
The Ministry of Food and Drug Safety (MFDS) approved KB Pharm to supply Maxigesic, the compound injection for relieving pain, in the nation on Monday.
Regulators authorized Maxigesic use in adults who immediately needs administration due to pain and those who have no other routes of administration but require short-term treatment of moderate to severe pain.
Maxigesic is an intravenous injection that combines two non-narcotic analgesics, 1000 milligrams of acetaminophen and 300 milligrams of ibuprofen. The drug is the first pharmaceutical product that contains both acetaminophen and ibuprofen in Korea.
In Korea, acetaminophen and ibuprofen compounds developed by Hanmi Pharmaceutical could not receive regulatory approval in 2017. Also, in May, MFDS revealed that classifying the compound drug as an over-the-counter drug and giving permission was not appropriate.
Maxigesic was originally developed by AFT Pharmaceuticals in New Zealand and sold as an over-the-counter drug but converted the use to manage moderate to severe pain after surgery.
KB Pharm, an affiliate of Chong Kun Dang, secured exclusive domestic development and marketing rights for Maxigesic by signing a deal with AFT Pharmaceuticals in November 2018. The contract will last for 15 years, beginning from the first date of sale.
Acetaminophen and ibuprofen, which make up Maxigesic, are the most widely used substances for reducing fever and pain.
According to a phase 3 clinical trial conducted by AFT Pharmaceuticals on 276 adult patients who complained of moderate to severe pain after a bunionectomy, Maxigesic showed significant pain relief within 10 minutes after administration.
As a compound injection, the drug demonstrated a superior pain-killing effect than a single administration of acetaminophen or ibuprofen drug with fewer cardiovascular and gastrointestinal side effects.
AFT Pharmaceuticals took advantage of the excellent performance and submitted for approval in 21 countries worldwide, including major European countries and Australia. It is also taking steps to receive support from the U.S. Food and Drug Administration (FDA) through its Belgium partner Hyloris Pharmaceuticals.
“Non-narcotic analgesic injection market still has a great unmet demand,” KB Pharm official said. “We will expand our share in the analgesic field by introducing a compound injection of substances widely used for killing pain and fever in Korea.”