Will this be needed
https://www.acsh.org/news/2021/08/05/bad-day-antibe-and-pain-patients-15716
Quote::
Unanswered questions
1. This trial was designed to evaluate drug safety, not efficacy. (The company calls it an "absorption, metabolism, and excretion (AME) study.") Given that safety was the endpoint, I'm a little surprised that the doses chosen were 75 mg and 100 mg – rather similar. More commonly, a safety trial would evaluate three different doses that are significantly different from each other, for example, 25, 50, and 100 mg. A larger range of doses would (presumably) make it possible to look for a dose-response relationship, which can help determine whether a given effect is real or artifactual.
2. Three of 35 enrollees who completed the 28-day dosing protocol had a spike in liver enzymes, but this spike was seen in only the high dose group. And this spike, which is anything but subtle, was not seen in earlier trials. This is not easily explained.
3. Despite the significant elevation in liver transaminases in three enrollees, there were no other markers that might suggest liver toxicity.
Best Guess
I don't know how Antibe makes this problem go away, especially since otenaproxesul would (presumably) be used chronically for pain and inflammation. Even if the drug is given at a lower dose, there will always be a red flag attached to it. And it is ironic (unfortunately so) that if otenaproxesul is withdrawn, it would be because of toxicity typical of Tylenol rather than that of traditional NSAIDs.