The analysis focused on the effect of doses administered at bedtime on FM symptoms, including pain, tenderness, fatigue, mood and EEG sleep physiology over eight weeks. The researchers hope to identify parameters that might be useful markers of drug effects.
Fibromyalgia is not well understood by the medical community. It is known, though, that certain people are more at risk of developing fibromyalgia than others. The symptoms of fibromyalgia can include everything from widespread pain to fatigue; menstrual pain to sleep disturbances. Because of the variety of fibromyalgia symptoms, there are a number of associated conditions linked to fibromyalgia.
The study showed that bedtime CBP was well-tolerated, with no serious adverse events or discontinuations due to adverse events. The safety profile of CBP compared favorably to that of placebo, and the types of treatment-emergent adverse events observed were relatively consistent with those reported in the Flexeril (immediate release CBP) product label. This study showed bedtime treatment with CBP improved core FM symptoms of pain, tenderness, fatigue, and depressed mood.
There are currently three drugs approved for the indication of FM: Lyrica, an analgesic; Cymbalta an antidepressant and Savella, whose active ingredient is marketed as an antidepressant in Europe. No medicine from the "muscle relaxant" category has been approved for FM. Lyrica, Cymbalta and Savella are all daytime treatments; and no bedtime medication has been approved for this indication.
Seth Lederman, M.D., Chairman and President of TONIX comments:
"We are pleased to have the results of our Phase 2a study, accepted for publication by The Journal of Rheumatology, which is a prestigious peer reviewed journal, and is a leading journal for FM clinical research. This study provides objective data supporting our novel approach to treating FM with CBP. We believe that TNX-102 represents an exciting and meaningful new potential treatment option for FM patients and we look forward to continued validation of our lead product candidate in additional studies as TONIX advances its clinical development program."
Since the cause of fibromyalgia is unknown, there is no fibromyalgia cure. However, by treating the symptoms one may be experiencing, a doctor should be able to provide some fibromyalgia relief. One aspect of treatment will likely include a medication listed above.
Fibromyalgia is considered a controversial diagnosis, due to lacking scientific consensus to its cause. Not all members of the medical community consider fibromyalgia a disease because of a lack of abnormalities on physical examination and the absence of objective diagnostic tests.
However, fibromyalgia has been recognized as a diagnosable disorder by the National Institutes of Health and the American College of Rheumatology.
The authors concluded in summary:
"Although the mechanism by which bedtime CBP acts remains unclear, this study demonstrates the potential for bedtime CBP to relieve pain, reduce fatigue, decrease tenderness, improve mood and improve sleep quality in patients with FM. The CAP rate may provide a novel biomarker for assessing treatment effects on non-restorative sleep and associated subjective somatic and mood symptoms in FM. Bedtime CBP may have an advantage of decreased drowsiness relative to higher daytime doses. In theory, CBP may have other advantages, since it is expected to have less potential for drug interaction or overdose, and may result in increased adherence as a result of once-daily dosing."
Written by Sy Kraft