Clinical Research: Phase 1 - Phase 4

PharmaLive – Trends and Challenges in Fibromyalgia Drug Research

It’s hard to fault fibromyalgia patients for feeling ignored and underserved. For years, many health professionals doubted and discounted their symptoms, even labeling them as malingerers. Physicians and researchers cannot easily or directly observe fibromyalgia’s manifestations, but must rely on patient reports of pain and a range of other symptoms. What’s more, no clear biomarkers are available to guide the condition’s management or measure response to treatment.

It wasn’t until the early 2000s that the affliction became more generally accepted as a syndrome, paving the way for FDA approval of three therapies: the anti-seizure medicine pregabalin and the serotonin and norepinephrine reuptake inhibitors duloxetine and milnacipran. But after that burst of activity, fibromyalgia largely fell off the pharmaceutical map until a rebirth of interest in 2012.

Research has since taken a diverse range of approaches. At one time, we had four programs running in entirely different methods of action: traditional approaches (serotonin-norepinephrine reuptake inhibitors, sedatives, muscle relaxants, and new chemical entities), antiviral products, electromagnetic and cranial stimulation devices, and behavioral therapy. Multiple new drugs are under study today, though none has yet received regulatory approval.

As the field has matured, it has become increasingly clear that fibromyalgia is a complex condition whose definition and measurement extend far beyond charting patient-reported pain levels on a numeric scale. While pain remains the condition’s primary symptom, improving quality of life requires more than just mitigating discomfort. Indeed, the FDA increasingly seeks evidence of overall benefit and functional improvement — and an online survey of nearly 2,600 patients revealed that the fatigue, sleep disturbance, and cognitive dysfunction are often more severe and problematic symptoms than pain.

Read more at PharmaLive.