Milnacipran for Treatment of Fibromyalgia (September) (CE) – Source: Annals of Pharmacotherapy, Aug 17, 2010

[Note: Milnacipran (Savella®) was the third drug to receive FDA approval for prescription to fibromyalgia patients.]

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of milnacipran and evaluate relevant clinical trial data.

Data Sources: MEDLINE, International Pharmaceutical Abstracts, and Google Scholar searches (1966-June 2010) were conducted using the key words fibromyalgia, milnacipran, and serotonin-norepinephrine reuptake inhibitor. Searches were limited to articles published in English.

Study Selection and Data Extraction: All available English-language articles of human studies were evaluated. One pharmacokinetic study reviewed included animal data. References cited in identified articles were used for additional evaluation.

Data Synthesis:
Milnacipran is a serotonin-norepinephrine reuptake inhibitor with a 3-fold increased selectivity for norepinephrine compared to serotonin.

It is well absorbed with 85%-90% bioavailability.

Maximum concentrations are achieved 2-4 hours after administration.

Milnacipran does not undergo cytochrome P450 metabolism and has a half-life of 6-8 hours.

Fifty-five percent of each dose is excreted unchanged in the urine.

Dose adjustment is needed in patients with an estimated creatinine clearance of <30 mL/min.

Clinical trials indicated that twice-daily dosing at 100 mg/day or 200 mg/day was superior to single-daily dosing.

Studies further established the effectiveness of both doses in the treatment of fibromyalgia pain utilizing patient self-reported pain scores, as well as on a visual analog scale, Patient Global Impression of Change scale, and the Short-Form 36 Physical Component Summary.

A 6-month extension trial, which evaluated patients continued on milnacipran for up to 1 year, demonstrated continued pain relief.

The most common adverse drug reaction associated with milnacipran was nausea, which was reduced with slow-dose titration and administration with food.

Milnacipran is an effective treatment option for patients with fibromyalgia.

More head-to-head clinical trials are necessary to assess its ultimate place in therapy.

Source: Annals of Pharmacotherapy, Aug 17, 2010. PMID: 20716692, by Kyle JA, Dugan BD, Testerman KK. Samford University, Birmingham, Alabama, USA. [Email:]

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