A new drug being tested in clinical trials to treat fibromyalgia, called Tonmya, is showing promise for sleep improvement and pain reduction.
Tonmya is being evaluated in the 500-patient Phase 3 AFFIRM study in fibromyalgia. The primary outcome measure for this study is a pain responder analysis, which basically means patients report a minimum of a 30% reduction in pain from their baseline after undergoing treatments for 12 weeks.
The drug is taken at night daily, and researchers are seeing that patients are seeing improvements in sleep.
“Our new analyses of the BESTFIT data show that those patients who reported the greatest improvement in sleep quality were the most likely to experience pain relief,” said Seth Lederman, M.D., Tonix’s chairman and CEO. “We also observed that the group treated with Tonmya was approximately twice as likely as placebo-treated patients to be in the top third of reported sleep quality improvement. Among all patients in BESTFIT who ranked highest in reported sleep quality improvement, twice as many Tonmya-treated patients experienced at least a 30% improvement in their pain as compared to those treated with placebo.”
Of the 172 evaluated, 88 patients were treated with Tonmya, and 84 were treated with a placebo. They found that 67% of those taking Tonmya were in the top tier of those reporting better sleep, and had at least 30% reduction in pain compared to the baseline.
In other analyses, the relationships between reported sleep quality and several standard measures of fibromyalgia were evaluated. According to each of the three different assessments of sleep quality, improvement in sleep quality was found to significantly correlate with improvement in pain as well as broader measures of fibromyalgia symptoms and impact.
Data from the study, which is being conducted by Tonix Pharmaceuticals, were presented this month at the 2015 American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Francisco, CA.
Tonix Pharmaceuticals says “These findings may support the hypothesis that improving sleep quality facilitates pain improvement over time, and is consistent with the growing recognition of a reciprocal relationship between sleep and chronic, widespread pain. Nonrestorative sleep has been linked to altered processes in the brain that are thought to be responsible for certain fibromyalgia symptoms.”