A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Inclusion Criteria:

• Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
• Male or female 18-75 years old
• For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
• Willing and able to withdraw specific therapies (ask PI)
• Medically acceptable form of contraception (female only)
• Signed informed consent

Exclusion Criteria:

• Arthritis, lupus and other systemic auto-immune diseases
• Regional or persistent pain that could interfere with assessment of fibromyalgia pain
• Bipolar and psychotic disorders
• Increased risk of suicide
• Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
• Inability to wash-out specific medications (ask PI)
• Known hypersensitivity to cyclobenzaprine
• Others: seizure disorders, severe/untreated sleep apnea, BMI>40