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

Inclusion Criteria:

- Male or female between 18 and 75 years of age, who have served in any branch of the
military.

- Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale
(CAPS-5) for DSM-5.

- Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in
CAPS-5, have occurred in 2001 or later, be military service related.

- Willing to refrain from use of all other formulations of cyclobenzaprine.

- Willing and able to refrain from antidepressants and other excluded medications.

- Capable of reading and understanding English and able to provide written informed
consent.

- If female, either not of childbearing potential or practicing a medically acceptable
method of birth control throughout the study.

- Willing and able to comply with all protocol-specified requirements.

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.