Najib Babul Explains Why Treatment Advances in Fibromyalgia Have Been Slow

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. Dr. Najib Babul, a prominent developer of medicines to treat pain offered some insight on reasons for slow advances in the field and what developments may be coming soon.

Fibromyalgia involves central amplification of peripheral sensory signals, so that otherwise normal sensations are perceived as painful.  Most patients afflicted with fibromyalgia also experience excessive tenderness, fatigue, sleep disturbances, problems concentrating, and functional impairment.  According to Dr. Najib Babul, “a major obstacle to diagnosis is the absence of specific laboratory or imaging tests for fibromyalgia, although lab testing can be used to rule out other conditions associated with fatigue.”  He adds, “Since the symptoms of fibromyalgia are shared with other conditions, patients should also be evaluated for mood disorders and sleep impairment.”

In the decades prior to the introduction of the American College of Rheumatology’s (ACR) classification criteria for fibromyalgia in 1990, there was considerable skepticism about fibromyalgia as a legitimate medical condition. The 1990 ACR criteria ushered in an era of increased recognition of fibromyalgia and provided a standardized diagnostic approach. This was a boon for clinicians and even more so for researchers looking to test the efficacy of drugs.  Despite widespread dissemination of the diagnostic criteria, skepticism abounded. For example, the very year ACR published the criteria for fibromyalgia, the British Journal of Rheumatology and the Canadian Family Physician journal published papers questioning the existence of fibromyalgia.  However, the ACR criteria provided a major boost to research, resulting in the 2006 FDA approval of pregabalin (Lyrica®); the 2008 approval of duloxetine (Cymbalta®); and the 2009 approval of milnacipran (Savella®), which remain the only FDA-approved medicines for the treatment of fibromyalgia.

Although the ACR classification system was a major advance, it proved problematic in a number of areas.  First, it required assessment of tenderness on pressure (tender) points in at least 11 of 18 specified sites and the presence of widespread pain for a diagnosis of fibromyalgia.  Second, tender point assessment failed to address the symptoms that bothered patients. And finally, digital palpation of 18 tender points was hard for most non-rheumatologists to perform. It became apparent that primary care physicians had neither the time nor the training to perform extensive tender point assessment. Therefore, in 2010, the ACR simplified its criteria, eliminating tender point assessment, and changed the definition of fibromyalgia to an illness characterized by self-reported multiple painful regions and core symptoms such as such as fatigue, sleep disturbances and impaired cognition. In 2011, the ACR modified those criteria further to develop a self-report version that could be used by both primary care providers and by clinical researchers, thus spurring further testing of treatments for fibromyalgia.

Dr. Najib Babul states that although there are no definitive treatments for fibromyalgia, evidence indicates that lifestyle changes including relaxation, patient education, counseling, and exercise all improve symptoms and should therefore be an active part of any management program. In recent years, several promising drug treatments have failed in clinical trials, although companies such as Astellas, Daiichi Sankyo, Zynerba and SWITCHBIOTECH are actively pursuing new treatments for fibromyalgia.  As awareness is raised and research studies continue, the contributing causes of fibromyalgia will be better understood and allow for the development of superior treatments.

Dr. Najib Babul, PharmD, MBA is an accomplished pharmaceutical scientist, drug developer, inventor, and biotech entrepreneur with over two decades of experience in bringing new drugs to market. Presently he provides consulting services to pharmaceutical companies, investment banks, and I.P. law firms, including licensing due diligence, orphan drug applications, Risk Evaluation and Mitigation Strategies (REMS), pediatric exclusivity, drug development planning, clinical trial design, and contract research organization (CRO) selection and management.  Dr. Babul is also the Director of Medical and Pharmaceutical Consulting at the California Institute of Advanced Management.


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