ABSTRACT
Introduction: Fibromyalgia (FM) is a chronic disorder whose symptoms of musculo-skeletal pain, fatigue, sleep disturbances, and cognitive impairment pervade the personal, occupational, and social aspects of a patient’s life. Together with the antidepressants duloxetine and milnacipran, the anticonvulsant pregabalin (PGB) is one of the three drugs approved by the Food and Drug Administration for the treatment of FM. The aim of this narrative review is to summarize the data relating to the efficacy and safety of the controlled-release formulation of PGB (PGB-CR) in patients with FM.
Areas covered: Efforts by the pharmaceutical industry have led to the introduction of new formulations of already approved drugs to enhance treatment convenience and adherence.
Expert opinion: Although there are no published studies specifically comparing PGB-CR and PGB-IR formulations in FM patients, the efficacy and safety profiles of PGB-CR seem to be similar to those of the IR formulation, and the convenience of once-daily dosing potentially enhances patient compliance. However, the amount of evidence is not sufficient to draw any definite conclusions, and further studies of larger patient samples are needed.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
One reviewer was an investigator on several pregabalin clinical trials, completed an investigator-initiated central nervous system biological mechanism study, and has served as a consultant to a Japanese company developing a competitor to pregabalin in the treatment of fibromyalgia. Peer reviewers have no other relevant financial relationships to disclose.