Phase 2 Study of TD-9855 to Treat Fibromyalgia

Inclusion Criteria:

- • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

- Informed consent

- 18 to 65 years of age

- Discontinue therapy with adrenergic-acting drugs, and certain other medications

- Only acetaminophen or NSAID as rescue pain medication

- No narcotic pain meds or benzodiazepines

- Only non-benzodiazepines as rescue hypnotics

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)