Sinew Pharma Inc. announced on the 27th that its acetaminophen-based pain relief drug SNP-810 (SafeTynadol), known for its high liver safety, combined with a non-addictive painkiller, successfully met the primary and secondary endpoints in its Phase I/II clinical trial for treating moderate to severe pain following knee replacement surgery.
This clinical trial is one of the studies involving SNP-810 as part of a new, potent pain relief formulation, and it is also the first time it has been tested on patients. The primary objective of this trial was to gather clinical safety, efficacy, and pharmacokinetic/pharmacodynamic data on SNP-810 when combined with the non-addictive painkiller. The goal of SNP-810 is to achieve both high liver safety and enhanced pain relief efficacy.
The trial was designed as a multi-dose, double-blind, single-center study. Patients 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 drugs. A total of 36 participants were enrolled in the study.
The trial results showed that participants who took the combination of SNP-810 and the non-addictive painkiller, at a dose of 650 mg/37.5 mg every 8 hours (three times daily), experienced significantly better pain relief compared to those who took either drug alone. Additionally, all three treatment groups maintained normal liver function.
According to the market data from the IMS Health and IMS National Sales Perspectives reports for 2014-2019, the global market for acetaminophen combined with opioid painkillers was approximately $950 million in 2019. Sinew Pharma noted that besides the combination of SNP-810 (SafeTynadol) with the non-addictive painkiller, there are currently no other similar competing products on the market. This new pain relief formulation has the potential to become a non-addictive, highly liver-safe, and potent oral painkiller in the future.
