Founder of Health Rising and Phoenix Rising
Tonix believes a sublingual form of cyclobenzaprine will be the first drug to reduce the problem of non-restorative sleep in Fibromyalgia. Non-restorative sleep is also the main sleep issue in ME/CFS (chronic fatigue syndrome)
Cyclobenzaprine (brand names Amrix, Flexeril and Fexmid) s a muscle relaxer medication used to relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions, that is also used off-label for fibromyalgia treatment. It has been shown to be effective in FM but has no proven benefit in reducing muscle spasms after about two weeks.
An earlier fibromyalgia trial found that very low dose cyclobenzaprine significantly improved pain, tenderness, and depression over eight weeks - indicating that very low doses of the drug can be effective for longer than two weeks when treating sleep in FM. An EEG indicated that significantly more people taking CBP group had increased nights of restorative sleep. The increase in nights with more restorative sleep was correlated to improvements in fatigue and reductions in depression.
Muscle spasms and tightness can often increase during sleep but the mechanism by which the drug is working is not clear. The authors of the study suggested, however, that the drug may be affecting serotonin levels (and reducing glutamate expression) and sympathetic nervous system functioning. Genetic linkages have associated FM with genes encoding receptors for these areas. Increased sympathetic nervous system functioning has been associated with poor sleep in ME/CFS. This earlier study clearly provided the genesis for this larger trial of sublingual cyclobenzaprine in FM.
Tonix CEO Dr. Seth Lederman stated “We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” . “If approved, we believe TNX-102 SL would offer a clinical profile that would be highly differentiated from currently-marketed drug products, and would be the first medicine for fibromyalgia to target non-restorative sleep.”
The company seems confident and is opening a huge trial in 35 sites. If you are interested in participating =contact Mark R. Schmal via e-mail firstname.lastname@example.org or + 1 512 852 6912. For a list of the 35 study locations recruiting participants please follow the link.