Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

Exclusion Criteria

• •Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
• •Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
• •Severe depressive symptoms at screening or baseline.
• •Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
• •Use of antidepressant medication within 2 months of baseline.
• •Female patients who are pregnant or lactating.
• •History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
• •Seizure disorder.
• •Patients with a body mass index (BMI) \> 45.
• •Has received any other investigational drug within 30 days before Screening.
• •Previous participation in any other study with TNX-102 SL.
• •Family member of investigative staff.