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Chronic pain and fibromyalgia: the regulatory perspective

https://doi.org/10.1016/S1521-6942(03)00045-7Get rights and content

Abstract

Chronic pain is an important clinical entity that represents a currently unmet medical need. Relief of pain is an important public health goal for patients of all ages, from perinatal to geriatric. This article will describe some of the current regulatory issues in developing and approving drugs to treat chronic pain. It will also begin to familiarize the reader with the importance of the so-called ‘label’ and some of its roles to enable the best ‘risk–benefit’ decisions be made for, and by, patients with chronic pain.

Section snippets

Chronic pain: the problem

According to the Merck Manual (2002, 17th edition), there are at least two different types of pain that are generally recognized: acute and chronic pain. Chronic pain is ‘usually defined broadly and arbitrarily as pain persisting >1 month beyond the resolution of an acute tissue injury, pain persisting or recurring for >3 months, or pain associated with tissue injury that is expected to continue or progress. Chronic pain has no adaptive biologic role. Vegetative signs (e.g. lassitude, sleep

Chronic pain: clinical and scientific issues

The mere fact that chronic pain exists, and so can be described in a textbook as noted above, suggests that pain relief with currently available drugs is not always adequate to eliminate pain. This may be because analgesics are not being utilized to their maximum clinical benefit. This can result from a variety of reasons but often it results from a dose-limiting adverse event. As an unintended consequence, this concept of ‘under-treatment’ might possibly allow pain to become chronic, primarily

Chronic pain: Issues related to FDA approval for marketing

Approval for marketing involves a complex procedure that involves review of all safety and efficacy information on the drug, at both the clinical and non-clinical level. It involves the successful completion of multiple clinical trials designed to understand many different but vital aspects of the drug, including its absorption, distribution, metabolism, elimination, drug interactions and manufacture as well as its ability to function as an analgesic for chronic pain in an acceptably safe

Chronic pain: the future

The potential of future analgesics to be more effective for chronic pain, and to be safer than existing therapies, seems brighter than ever. In genomics and proteomics, revolutions are underway which hold promise to allow more targeted and safer treatments at both group and individual level. The issue of how much this future applies to fibromyalgia is as yet unknown. What role should the FDA play in this future? Should the FDA develop a guidance document to facilitate drug development for the

References (4)

  • NIH-FDA analgesic drug development workshop: translating scientific advances into improved pain relief. Clinical...
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The views expressed are those of the authors. No official support or endorsement by the US Food and Drug Administration is provided or should be inferred. No commercial interest or other conflict of interest exists between the authors and the manufacturers of the products.

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