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



Status:Completed
Conditions:Chronic Pain, Fibromyalgia, Neurology, Neurology, Neurology, Orthopedic, Rheumatology, Pain
Therapuetic Areas:Musculoskeletal, Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:12/14/2017
Start Date:April 2015
End Date:September 2016

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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 strong 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.

- Unability to wash-out specific medications (ask PI)

- Known hypersensitivity to cyclobenzaprine

- Others: seizure disorders, severe/untreated sleep apnea, BMI>40
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