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SAVELLA (MILNACIPRAN): CLINICAL STUDIES

Management of Fibromyalgia

The efficacy of Milnacipran HCl (Savella) for the management of fibromyalgia was established in two double-blind, placebo-controlled, multicenter studies in adult patients (18-74 years of age). Enrolled patients met the American College of Rheumatology (ACR) criteria for fibromyalgia (a history of widespread pain for 3 months and pain present at 11 or more of the 18 specific tender point sites). Approximately 35% of patients had a history of depression. Study 1 was six months in duration and Study 2 was three months in duration.

A larger proportion of patients treated with Milnacipran Hydrochloride (Savella) than with placebo experienced a simultaneous reduction in pain from baseline of at least 30% (VAS) and also rated themselves as much improved or very much improved based on the patient global assessment (PGIC). In addition, a larger proportion of patients treated with Savella met the criteria for treatment response, as measured by the composite endpoint that concurrently evaluated improvement in pain (VAS), physical function (SF-36 PCS), and patient global assessment (PGIC), in fibromyalgia as compared to placebo.

Study 1: This 6-month study compared total daily doses of Savella 100 mg and 200 mg to placebo. Patients were enrolled with a 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.

Study 2: This 3-month study compared total daily doses of Savella (Milnacipran) 100 mg and 200 mg to placebo. Patients were enrolled with a minimum mean baseline pain score of >= 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.

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 with a stable dose of Savella (Milnacipran HCl) that persisted throughout these studies.



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Trade name of the drug Pharmaceutical forms and doses Companies
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