On the 27th, Sinew Pharma announced that its new high liver safety acetaminophen-based painkiller, SNP-810 (brand name Antainatone), combined with a non-addictive potent painkiller, has successfully met the primary and secondary endpoints in a Phase I/II clinical trial for the treatment of moderate to severe pain following knee replacement surgery.
This clinical trial is one of the studies evaluating SNP-810 when used in a new potent analgesic combination, and it marks the first time this combination has been tested in patients. The primary goal of the trial was to obtain clinical safety, efficacy, and pharmacokinetic/pharmacodynamic data for SNP-810 and the combined non-addictive painkiller in patients. The hope for SNP-810 is to achieve high liver safety and better pain relief.
The clinical trial was designed as a multi-dose, double-blind, single-center study. Participants who underwent knee replacement surgery were randomly divided into three groups: one receiving oral SNP-810, one receiving the non-addictive painkiller, and one receiving a combination of both SNP-810 and the non-addictive painkiller, with a total of 36 participants enrolled.
The trial results showed that participants who took the combination of SNP-810 and the non-addictive painkiller experienced significantly better pain relief compared to those who took either SNP-810 or the non-addictive painkiller alone. Specifically, the combination dosage was 650 mg/37.5 mg of SNP-810/non-addictive painkiller, administered once every 8 hours, three times a day. Importantly, all three treatment regimens maintained normal liver function.
From a market perspective, according to the IMS Health and IMS National Sales Perspectives report (2014-2019), the global market for acetaminophen combined with opioid analgesics was approximately $950 million USD in 2019. Sinew Pharma noted that aside from the combination of SNP-810 and the non-addictive painkiller, there are currently no other similar competing products on the market. This new analgesic combination is expected to become a non-addictive, high liver safety, potent oral painkiller in the future.
Resource (mandarin): 欣耀生醫高肝安全性止痛新藥SNP-810合併強效止痛新複方
