Sinew Pharma (6634) announced that its acetaminophen-based pain relief drug SNP-810 (SafeTynadol), known for its high liver safety profile, has completed its Phase I/II clinical trial for treating moderate to severe pain after knee replacement surgery, in combination with a non-addictive pain relief drug. The trial results indicated that both primary and secondary endpoints were met, and normal liver function was maintained. This development positions Sinew Pharma to potentially tap into a market worth over $950 million.
This clinical trial is one of the tests evaluating the combination of SNP-810 with a potent non-addictive pain reliever. It is also the first trial in which the drug was tested on patients. The primary objective was to gather clinical safety and pharmacokinetic/pharmacodynamic data for SNP-810 in combination with the non-addictive pain reliever in patients. The goal of SNP-810 is to achieve a high level of liver safety along with improved pain relief efficacy.
The trial was designed as a multi-dose, double-blind, single-center study. Patients undergoing knee replacement surgery were randomly divided into three groups: one receiving oral SNP-810, one receiving the non-addictive pain relief drug, and one receiving a combination of SNP-810 and the non-addictive pain reliever. A total of 36 participants were enrolled in the trial.
The results showed that participants who received the combination of SNP-810 and the non-addictive pain reliever, at a dosage of 650 mg/37.5 mg every 8 hours (three times daily), experienced significantly better pain relief compared to those who received either drug alone. Moreover, all three treatment methods were able to maintain normal liver function.
According to the IMS Health and IMS National Sales Perspectives reports from 2014-2019, the global market for acetaminophen combined with opioid pain relievers reached approximately $950 million in 2019.
Sinew Pharma pointed out that aside from the combination of SNP-810 (SafeTynadol) with the non-addictive pain reliever, there are currently no other similar competitive products on the market. This new pain relief formulation is expected to become a highly liver-safe, non-addictive, and potent oral pain reliever in the future.
Sinew Pharma stated that they have commissioned a consulting firm to complete a comprehensive trial report, and they will use the final report to apply for regulatory review. They may consult with domestic and international health authorities to discuss whether further research is necessary for market approval.
