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Tonix Pharmaceuticalsreports that there is a potential new fibromyalgia drug for fibromyalgia sufferers which is the first in more than a decade!!!
Tonix Pharmaceuticals announced that “TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia in the Phase 3 RELIEF study (Table 1). TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, taken once daily at bedtime, being developed for the management of fibromyalgia. RELIEF was a 14-week randomized, double-blind, placebo-controlled trial of TNX-102 SL 5.6 mg, in which 503 participants with fibromyalgia were randomized in a 1:1 ratio across 39 U.S. sites. All participants received one tablet of TNX-102 SL (2.8 mg) or placebo for the first two weeks, which was increased to two tablets of TNX-102 SL (5.6 mg) or placebo for the remaining 12 weeks.“
“Tonix is dedicated to improving the lives of the millions suffering from fibromyalgia, approximately 90% of whom are female, and the results of the RELIEF trial bring new hope to this community,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.
This is music to all fibromyalgia sufferers ears and hopefully something that will soon be available for sufferers to try. More details on the study can be found on Tonix Pharmaceutical website and also on Fed Up With Fatigue’s website which also has a link for any fibromyalgia patients who may wish participate in the trial.
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KnowYourMeds is a for-profit social enterprise that seeks to improve healthcare globally using AI. We have developed an intelligent [AI] Digital Health Assistant [DHA] for Providers, Self Insured Employers/Payors and Patients.
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There is also a great blog with information on Diseases, Drugs and Digital Health.
According to a recent article in Pro Health there are four drugs that might be effective as a Fibromyalgia treatment. Although these four drugs are not knew ones they could still help with Fibromyalgia. These drugs will likely never be the subject of big clinical trials because there’s little profit to be made given their age. However, that doesn’t mean they aren’t effective.
1. Ketamine –
A growing number of pain clinics are now offering ketamine infusions for chronic conditions like fibromyalgia, but do they actually work? Early research suggests they may – at least temporarily.
In a small Swedish study, 11 fibromyalgia patients were randomly selected to receive either a low-dose ketamine infusion or a placebo infusion. Eight of those patients experienced at least 50% less pain using ketamine.
How can one drug hold such promise and peril? The answer lies in how it affects your brain.
Ketamine works like a flash mob, temporarily taking over a certain chemical “receptor.” In some cases and with expert medical care, that can be a good thing. But cross that line, and it’s big trouble.
Sometimes the brain fog caused by fibromyalgia literally can feel like early-stage dementia so it isn’t surprising that an Alzheimer’s drug might be helpful in treating fibro.
Memantine is frequently used for moderate-to-severe Alzheimer’s disease, but two small Spanish studies have shown it may benefit those with fibromyalgia, too. In 2014, researchers from the University of Zarogoza reported memantine significantly reduced fibromyalgia pain when administered to 63 patients at a dosage of 20 mg per day.
The subgroup of patients who had undergone pharmacological treatment of [insulin resistance] with metformin, in combination with the [standard treatment], experienced a dramatic decrease in pain scores,” reads the study. “Response to metformin plus [standard treatment] was followed by complete resolution of pain in eight of 16 patients who had been treated with metformin, a degree of improvement never observed before in such a large proportion of fibromyalgia patients subjected to any available treatment.
4. Naltrexone ( low dose) –
Low-dose naltrexone (LDN) is the dark horse of the fibromyalgia community. Very few patients and doctors know about it, and yet I frequently hear from persons with fibromyalgia who say LDN has changed their lives for the better.
An opioid receptor antagonist, naltrexone has been used to treat alcohol and drug dependence since the 1980s at full doses of 50 mg or higher.