The Food and Drug Administration (FDA) approval of a new treatment for a chronic pain condition represents a major breakthrough, according to specialists in the field of pain management.

Fibromyalgia is a chronic pain condition that is usually accompanied by poor sleep, stiffness and fatigue; sufferers also report experiencing deep tenderness, soreness and flu-like aching.  The pain of fibromyalgia can hamper a patient’s ability to work and often results in increased medical costs and disability.

Fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful.  Lyrica binds to a specific protein within overexcited nerve cells and works to calm damaged nerves. 

Lyrica’s approval for fibromyalgia represents the eighth Pfizer treatment to receive “priority review” status from the FDA over the past two and a half years.  In addition to Lyrica’s initial approval for the management of neuropathic pain associated with diabetic peripheral neuropathy, other priority reviews included Sutent for advanced kidney cancer and gastrointestinal stromal tumors and Champix for smoking cessation.

“A major part of Pfizer’s strategy – both globally and within the Middle East region – is to look to develop treatments for conditions where there is a huge unmet medical need,” said Dr. Ahmed El Hakim, Director, External Affairs & Policy, Middle East Region, Pfizer. “We are now seeing the results of our comprehensive research investment in the value that the new treatment will bring to patients suffering from fibromyalgia.”

In clinical trials, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo.  In addition, patients taking Lyrica reported feeling better and improvements in physical function.

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