Savella (milnacipran hydrochloride)

Company
Forest Laboratories

Approval Status
Approved January 2009

Treatment for
fibromyalgia

Areas
Musculoskeletal

Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor. It affects the two neurotransmittersalmost equally (a 3:1 norepinephrine to serotonin balance). However, the exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown.

Savella is specifically indicated for the management of fibromyalgia in adults.

Savella is supplied as a tablet designed for oral administration. The recommended initial dose of the drug is 100 mg/day (50 mg twice daily). Dosing should be titrated according to the following schedule:
Day 1: 12.5 mg once Days 2-3: 25 mg/day (12.5 mg twice daily) Days 4-7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)

Doses above 200 mg/day have not been studied.

FDA Approval
FDA approval of Savella was based on the results of two clinical trials.

Study One
This 6-month double-blind, placebo-controlled, multicenter study enrolled adult patients (18-74 years of age). The subjects received daily doses of Savella 100 mg and 200 mg or placebo. The minimum mean baseline pain score of >50 mm on a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). The mean baseline pain score in this trial was 69. More patients in the Savella treatment arms experienced at least a 30% reduction in pain from baseline (VAS) and considered themselves globally improved (PGIC) than did patients in the placebo arm.

Study Two
This 3-month, double-blind, placebo-controlled, multicenter study enrolled adult patients (18-74 years of age). The subjects received daily doses of Savella 100 mg and 200 mg or placebo. The minimum mean baseline pain score was >40 mm on a 100- mm VAS ranging from 0 (no pain) to 100 (worst possible pain). The mean baseline pain score in this trial was 65. improvement. More patients in the Savella treatment arms experienced at least a 30% reduction in pain from baseline (VAS) and considered themselves globally improved (PGIC) than did patients in the placebo arm.

In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment.

Ongoing Study Commitments

  • Forest Labs has agreed to a deferred pediatric study under PREA for the management of fibromyalgia in pediatric patients ages 13 through 17.
    Protocol Submission: July 2009
    Study Start Date: January 2010
    Final Report Submission: October 2014
  • Forest Labs has agreed to develop and maintain a prospective, observational pregnancy exposure registry study conducted in the United States that compares the pregnancy and fetal outcomes of women exposed to Savella (milnacipran HCl) during pregnancy to an unexposed control population. The registry will detect and record major and minor congenital anomalies, spontaneous abortions, stillbirths, elective terminations, and any serious adverse pregnancy outcomes. These events will be assessed among the enrolled women throughout the pregnancy. The events will also be assessed among infants through at least the first year of life. Annual interim reports will be submitted until FDA has acknowledged that sufficient data have been collected.
    Protocol Submission: July 2009
    Study Start Date: January 2010
    Final Report Submission: Within six months of FDA notification that sufficient data have been collected.
  • Forest Labs has agreed to a single-dose, pharmacokinetic, open-label, clinical trial in healthy, lactating women. Concentrations of Savella (Milnacipran HCl) will be assessed in maternal plasma and breast mild so as to estimate potential infant exposure.
    Protocol Submission: August 2009
    Trial Start Date: August 2010
    Final Report Submission: February 2012
Adverse events associated with the use of Savella may include, but are not limited to, the following:
  • Nausea
  • Headache
  • Constipation
  • Hot flush
  • Hyperhidrosis
  • Vomiting
  • Palpitations
  • Heart rate increased
  • Dry mouth
  • Hypertension

Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor. It affects the two neurotransmittersalmost equally (a 3:1 norepinephrine to serotonin balance). However, the exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown.

For additional information regarding Savella or fibromyalgia, please visit the Savella web page.
Savella (milnacipran hydrochloride) Drug Information

The Savella (milnacipran hydrochloride) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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