If NDA Was expected sooner! This news coulda did great things for the price here. Oh well whatayado! Hehehe
$Tonix Pharmaceuticals (TNXP.US)$ Tonix Pharmaceuticals Announces Potential Positive Impact of the U.S. National Academies (NASEM) New Definition of Long COVID on the Size of the Fibromyalgia Market for Tonmya
July 31, 2024 8:00am EDT
Fibromyalgia is a "diagnosable condition" in people suffering from Long COVID according to NASEM1
Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2
Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025
July 31, 2024 8:00am EDT
Fibromyalgia is a "diagnosable condition" in people suffering from Long COVID according to NASEM1
Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2
Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025
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Arrayfunction : Ignore all the fluff about COVID there. Here is the meat of it:
"Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation:"
(If I knew how to highlight or bold in comments or find the comments on the desktop version, I would emphasize first-line non-opioid analgesic)
That means $$$ for the drug because an FDA indication like that would be a mushroom cloud explosion in market share. With the US regulations on opioids these days, most fibromyalgia patients can't actually get pain treatment from their primary care doctors because it's too risky for them (practically speaking, they can only prescribe the anti-seizure meds or anti-depressants. These can be effective, but not at reliable rates and have pretty bad side effects).
Up until recently, a patient would have to wait months to get into a rheumatologist if they wanted pain relief. Even that's become a new barrier. Rheumatologists have gotten so annoyed by other doctors punting chronic pain patients their way by slapping the "fibromyalgia" label on them (which no test can prove/disprove) that they have started rejecting referrals with only "fibromyalgia" as an indicator. That assumes a patient can afford a rheumatologist and doesn't get fed up waiting and abandons care.
GPs give out the pill form of cyclobenzaprine all the time without worry. Chronic pain is one of the largest untapped markets in medicine with the aging populations and pull back on opioid use. I wouldn't be surprised to see this jump into the top 15 most prescribed medications within a year or two if it all plays out.
TL;DR Black Friday deals if you want to go long
Trytosaveabit OP : Yeah Covid I don’t believe 90% of what our government says! And on the pain / opioid front! I Would be willing to bet that I have far more firsthand knowledge/experience of the troubles that have come since the same Covid lying government got involved and decided to use prescription opioids as a scapegoat to cover their severely incompetent and lack of desire to go after fentanyl because that’s hard! So go after 99% of law abiding Dr’s and patients. Well because they are law abiding and they won’t fight back much! Same line as going after legal gun owners! But criminals who are not allowed to have guns get caught doing a crime with a gun they are not allowed to have and they lower the charges! Same with opiates! Legally prescribed is a awful ordeal! But they will give clean needles and safe places to shoot and ignore the open air drug markets! Grrrrrrr! Im done before I throw this screen across the room!
Lnova : That is good news because Fibromyalgia isn’t easy to treat I think. I have Trigeminal Neuralgia and there isn’t a cure for it, there are only some treatments like surgery, anti-convulsants to treat the nerve problem, and pain killers. Ibuprofen doesn’t work on it, the condition isn’t receptive to whatever ibruprofen does to ease pain
Lnova : So that could be substantial to patients who are going through a hard time w/ their fibromyalgia
Trytosaveabit OP Lnova : All I can truly say on the subject! Is anything that has a chance to help anyone that suffers from chronic debilitating pain im 1000% for! Just trust that I know all to well how horrible some suffer everyday!
Lnova Trytosaveabit OP : Yeah that is cool that they are working on stuff like that, I didn’t know until you shared that now. I knew of the stock but I didn’t know what the company did. Tysm
Trytosaveabit OP Lnova : You’re very welcome.![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
Lnova Trytosaveabit OP : I used to be prescribed Lyrica and opioids for my Trigeminal Neuralgia and taking both medications together was at least decent treatment. But the two things helped the pain in different ways. Opioids helped most when I had Trigeminal Neuralgia pain, but this was years and years ago. And it was often difficult in some way to get my Opiod Rx because of it being a controlled substance or w/e, and can’t find out if pharmacies have it in stock over the phone in some states, so it’s hard to know where to even send your prescription to. Difficult
Trytosaveabit OP Lnova : Yes like I said in this feed I know all to well the difficulties in the bureaucracy that’s a total farce! Ill be brief! After years of no issues I ended up having to meet with the head of the department of health in my state so she could write off on my morphine prescription. After reading my file and meeting with me she even said that the new rule had been put in place as a guide/reference and not a law or a specific one size fits all! But now that it’s there some with a need to throw around their authority have scared Dr’s across the US into being afraid for their license if they were to prescribe over the MMO guidelines! Im just thankful she wasn’t one of them and was/is truly a advocate for patients! At least in my case!
Lnova Arrayfunction : yeah I have Trigeminal Neuralgia that used to be most severe pain like 10 yrs ago when it first started and I was first diagnosed, and some of the other medications I had weird reactions to, I think I was allergic to Tegretol/Carbamazepine. It made my face red like I was sunburned and gave a weird sensation behind my eyes, it was really strange. And I didn’t like Gabapentin. So I was on Lyrica which was fine but did not treat the pain 100% only partially. I was also prescribed oxy and that along with the Lyrica worked but it had its own complications being able to fill the oxy prescription and stuff. More medications to treat nerve and pain issues could be helpful for patients
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