BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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 (ACR criteria)
• Male or female 18-65 years old
• For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent 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-off specific medications (ask PI)
• Known hypersensitivity to cyclobenzaprine
• Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40