Antidepressants Ease Pain for Fibromyalgia Patients

An analysis of previous studies shows that the use of antidepressant medications by patients with fibromyalgia syndrome is associated with a reduction in pain, sleep disturbances, and depressed mood, and improvement of health-related quality of life (HRQOL).

Winfried Häuser, MD, of Klinikum Saarbrücken, Saarbrücken, Germany, and colleagues conducted a meta-analysis to evaluate the effects of treatment with antidepressants on fibromyalgia-related symptoms in 18 randomized controlled trials, involving 1,427 participants.

Strong evidence for a reduction of pain, fatigue, and depressed mood and improved sleep and HRQOL was found in fibromyalgia patients who used antidepressants.

The researchers found large effect sizes of tricyclic and tetracyclic antidepressants (TCAs) for reducing pain, fatigue, and sleep disturbances; small effect sizes of selective serotonin reuptake inhibitors (SSRIs) for reducing pain; small effect sizes of serotonin and noradrenaline reuptake inhibitors (SNRIs) for reducing pain, sleep disturbances, and depressed mood; and small effect sizes of monoamine oxidase inhibitors (MAOIs) for reducing pain.

The study is published in the January 14 issue of JAMA.

Low-Dose Version of Schizophrenia Drug Helpful for Sleep Maintenance Insomnia

Intra-Cellular Therapies Inc, New York, achieved successful top-line efficacy results for ITI-007 from a Phase II trial in sleep maintenance insomnia. The data demonstrate that ITI-007 is safe and well tolerated and is effective in reducing sleep disturbances.

ITI-007 is the company’s first-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatment of schizophrenia. A low dose formulation of ITI-007 whose actions are predominantly mediated by 5HT2A receptor antagonism is being developed for the treatment of sleep maintenance insomnia.

"The results that we have analyzed to date from this study are encouraging. Based on the robustness of the effects observed at the interim analysis, and after extensive consultation with outside sleep experts, we have decided to conclude this phase of the trial for ITI-007 ahead of time with only half of the planned enrollment," says Sharon Mates, chief executive officer of Intra-Cellular Therapies. "We are now moving forward with an analysis of all other outcome measures and look forward to the continued development of ITI-007 in patients who suffer from primary or comorbid insomnia.”

GlaxoSmithKline Resubmits New Drug Application for RLS Drug

GlaxoSmithKline has resubmitted the New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) extended release tablets for the treatment of moderate-to-severe primary restless legs syndrome (RLS). GlaxoSmithKline is resubmitting the application following a request by the FDA that the data in a single study be reformatted. Following this request, GlaxoSmithKline also conducted a review of other clinical studies.
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