Maintenance of Efficacy.

A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

Inclusion Criteria:

• Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
• Pain score greater than or equal to 4 on an 11-point NRS
• FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

• Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
• Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
• Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;