Presented at the 2012 AAPM Annual Meeting « Back

A 3-Year, Open-Label, Flexible-Dosing Study of Milnacipran for the Treatment of Fibromyalgia

Lesley M. Arnold, MD, arnoldlm@ucmail.uc.edu¹, Yimin Ma, PhD², Robert H. Palmer, MD², Allan Spera, PhD², Arlene Baldecchi, BS MT (ASCP) CCRA², (1) University of Cincinnati College of Medicine, Cincinnati, Ohio, (2) Forest Research Institute, Jersey City, New Jersey

Introduction: In this open-label study, treatment effects of milnacipran were evaluated in fibromyalgia patients (N = 1227) over a period that could exceed 3 years. Methods: Patients successfully completing previous milnacipran studies were eligible for enrollment. This study consisted of a 2-week washout period, a 2-week dose-escalation period (to milnacipran 100 mg/day), an 8-week stable-dose period (at milnacipran 100 mg/day), and a flexible-dose period (milnacipran 50-200 mg/day) for the remainder of the study. Key efficacy outcomes included VAS 24-h and weekly recall pain (0-100 scale), Patient Global Impression of Change (PGIC), Patient Global Disease Status (PGDS), SF-36 Physical Component Summary (PCS), and the Brief Pain Inventory (BPI). Efficacy results are reported as mean changes from study baseline following the 2-week washout period. The study protocol was approved at each site by an IRB; all patients provided written, informed consent. Results: Of the 1227 patients, 47.7% were considered completers; 206 reached the final visit, and 379 were enrolled when the study terminated. At the final visit, milnacipran-treated patients demonstrated a mean improvement from baseline in VAS 24-h recall pain scores of 23.1 points (observed cases). Similarly, patients showed improvements in VAS weekly recall pain, BPI scores, global status (PGIC, PGDS), and physical function (SF-36 PCS). The most common treatment-emergent adverse events over the 3-year period were nausea, headache, hypertension, and sinusitis. Conclusions: These findings provide support for sustained long-term efficacy (in some cases exceeding 3 years of continuous usage) and tolerability of milnacipran in the treatment of fibromyalgia.

Funding: This study was supported by Forest Research Institute, a subsidiary of Forest Laboratories, Inc. and Cypress Bioscience, Inc.