Good overview on why I am bullish
Sticking with $Tonix Pharmaceuticals (TNXP.US)$ has sure been a ride in the red 😆 This article does a good job explaining why I am confident their drug has a huge market share waiting for it.
Small grain of salt since it is sponsored content. The science and market data all check out. To my expertise level of a chronic pain patient who spends too much time on Pubmed to cope with the constant shaming faced by clinicians that is.
Buried in those references (going from Wikipedia to The Lancelet and Nature was interesting to see) is the reality that fibromyalgia is no longer being considered auto-immune by (US at least) rheumatologists. From what I have gathered, they are mostly just sick of being the ones stuck with those patients.
Fibromyalgia isn't something you can actually test for; the condition is "diagnosis by exclusion" (i.e. "We checked for everything else but we still have no clue"). A lot of GPs aren't confident in their ability to treat it (current non-opioid medications are truthfully garbage) and will dump those patients onto pain specialists or rheumatologists. Then whichever of the two specialists a patient can see first will say to go to the other one.....who will say to go back to the first one.
The sad reality is that it doesn't actually matter whether a doctor believes the pain is real or not. You just aren't worth the liability they take on to treat you from a business perspective. Fibromyalgia isn't a danger to life and pain is a "subjective measure" (vs something "objective" like brain lesions in MS).
Treating pain with opioids (even those FDA approved for nerve pain like tapentadol) has a legal risk due to (well-intentioned but heavy-handed) DEA and state policies to combat abuse. Understandably, doctors value their career more than any particular patient's quality of life and don't want to be the one stuck writing opioids.
Pain specialists and rheumatologists can simply refuse to accept a referral to avoid patients. GPs can't do that as easily ("preventative care" has more legal protections for patient access - so they will flock to having an effective drug they can prescribe without the legal risk
Soap box over 😇
Notice how they skimmed over what the sublingual dosing adds to the equation. Cyclobenzaprine has been used in pill form for decades. Dosing under the tongue will change the pharmacokinetics with faster absorption. But it seems more like they just needed a way to make it patentable to justify paying to get it FDA approved for fibromyalgia. (Similar to JnJ's es-ketamine nasal spray; racemic ketamine would have worked fine if they didn't want to charge $900 per two pump bottles)
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