(Reuters) - Tonix Pharmaceuticals Holding Corp said on Tuesday its experimental drug failed to meet the primary goal in a mid-stage study for management of widespread muscle pain and tenderness associated with long COVID-19. Shares of the company were down 12% in premarket trading. The 63-patient study was designed to monitor the intensity of pain in patients who had long COVID and administered either the drug, TNX-102 SL, or placebo, but the trial failed to show improvement at week 14 of treatment, the company said. However, the study showed that the drug helped reduce fatigue and improve sleep quality and cognitive function in the patients, the company said. Tonix intends to meet officials from the U.S. Food and Drug Administration in early 2024 to seek permission to conduct a late-stage trial that focuses on reducing fatigue in patients with long COVID, an illness with no approved drugs. Article here Clinicaltrial.gov link to drug trial here It looks like this drug has been tried for fibromyalgia patients
Well to be honest, they had to report the news and it's been fairly bad year for them in the stock market.. https://finance.yahoo.com/quote/TNXP/ It sounds to me like they are trying to keep hope alive by trying to turn around and use the drug for other purpose than pain- and it's the wrong way to try to address a complex illness with still very murky pathology. Basically they are throwing spaghetti at the wall and see how many stick.
TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. Old drug.
Drug trials have different requirements than behavioral stuff. In that they have actual requirements. And standards. And some accountability. Because rich people's money is involved. It's easy to see why there are strong incentives not to report them, given the drop on their stock price. Compound that with the complete absence of any accountability in behavioral trials when false positives are made up entirely. This is why there are such requirements in drug trials, and why there needs to be the same in clinical psychology, they'll just keep making stuff up until then. Then again the Mahana therapeutics experiment with their commercial CBT may represent a new frontier here. Normally it's academics or medical institutions who made stuff up about fake results, all protected by "muh academic freedom". No market pressure, no regulatory obligations. But here it's a company with a significant market share that is taking on those false claim. Eventually the hype will be revealed for what it is, and the company will fold within a few years. Smaller, but just as embarrassing and fraudulent as Theranos. A good example is how the STAR*D trial was done by academics, instead of a drug company. Although there are huge pharmaceutical interests behind it, medical secrecy added that extra ability to defraud, to hide their data and simply not respond, since they're exempt from some requirements that private companies have to comply with. Mostly because investors want to know they're not investing in quackery. Investors have far more protections than patients, it's not even close. Their investments are protected. Capitalism has many faults, but supply and demand work best for some things. Medicine has been largely immune from this, even in the US system, because there is 10-100x more demand than there is supply, they simply never run out of business, even when they deliver nothing of value. But investors want a return, and with behavioral pseudoscience they won't be getting it. It's a lot easier to do regulatory capture when you are the regulator.
