Phase 2 Study of TD-9855 to Treat Fibromyalgia

Exclusion Criteria

• •Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
• •Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
• •Risk of suicide (investigator opinion and/or C-SSRS)
• •Recent history of substance or alcohol abuse
• •BMI \<18 or ≥45
• •Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
• •Abnormal lab values (liver, kidney, thyroid, and others)