Fibromyalgia drug nearing approval after a 16-year lull
As Tonix awaits FDA decision, Axsome receives refuse-to-file letter
After 16 years without a new approval, fibromyalgia patients may be on the cusp of getting a therapy that improves pain, sleep and fatigue — the triad of symptoms that define the chronic condition.
While the biological underpinnings of fibromyalgia, a condition that predominantly affects women, are poorly understood, the etiology is thought to involve “a change in the brain’s interpretation of external stimuli” called nociplastic pain, Seth Lederman, CEO of Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), told BioCentury. That change is “not limited to the sensation of touch; it affects all senses and causes widespread pain.” ...
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