Recent strategies for drug development in fibromyalgia syndrome

Abstract

The US Federal Drug Administration (FDA) approved 3 medications for treating fibromyalgia syndrome (FMS). There have been no additional FDA approvals since January 2009 and the efficacy of the FDA-approved medications for FMS has been questioned. Areas covered: The "search for studies" tool using clinicaltrials.gov and PubMed were employed. The term, "fibromyalgia" was used for clinicaltrials.gov. The terms employed for PubMed were "Name-of-Drug Fibromyalgia", "Fibromyalgia Treatment" or "Fibromyalgia Drug Treatment." Clinical trials were reviewed if they were prospective and blinded, and if they employed a comparator, either placebo or another pharmaceutical. Expert commentary: Progress toward standardizing the outcome measures for FMS clinical trials have been made but challenges remain. Several pharmaceutical candidates for FMS have been tested since 2009. The results of these studies with potential novel targets for drug development for FMS were reviewed including the results of trials with sodium oxybate, quetiapine, esreboxetine, nabilone, memantine, naltrexone, and melatonin.

Melatonin Plus Folic Acid Treatment Ameliorates Reserpine-Induced Fibromyalgia: An Evaluation of Pain, Oxidative Stress, and Inflammation

“…Treatment of fibromyalgia requires a pharmacological approach focused on all symptoms with an emphasis on pain. Several pieces of evidence indicate that melatonin can be useful and suitable in fibromyalgia treatment thanks to its different properties [24][25][26]. It is a highly conserved indoleamine with chronobiological features [27].…”

Oral Supplementation of Melatonin Protects against Fibromyalgia-Related Skeletal Muscle Alterations in Reserpine-Induced Myalgia Rats

“…Recent evidence suggests that melatonin may be suitable and useful because of its multitasking properties as shown in several clinical studies [ 22 , 23 , 24 ]. Melatonin is a small, highly conserved indoleamine with important chronobiological features [ 25 ].…”

Use of Complementary and Integrative Therapies by Fibromyalgia Patients: A 14-Year Follow-up Study

“…Melatonin has antinociceptive, anti-inflammatory, and analgesic properties and has an important role in the pathophysiology of pain; 38e40 therefore, it may be an effective tool in the management of FM-related musculoskeletal pain. 41,42 In reserpine-induced FM in rats, melatonin reduced oxidative stress, inflammatory musculoskeletal changes, and difficulties with motor activity. 41 The efficacy of melatonin in humans with FM has been documented in several clinical trials (reduced tender point count, severity of pain, and Fibromyalgia Impact Questionnaire score; improved sleep quality), with a high level of confirmation 38,43e45 and limited adverse effects.…”