Fibromyalgia is a pain disorder.
Tonix is developing TNX-102 SL* as a potential treatment for the symptoms of Fibromyalgia. It is currently in Phase 3 clinical development. TNX-102 SL targets mechanisms which are associated with disturbed sleep. It is believed that increasing sleep quality in fibromyalgia may facilitate the body's adaptive ability to modulate the perception of pain.
TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. The dose of TNX-102 SL being studied in fibromyalgia is two tablets, or 5.6 mg of cyclobenzaprine each night at bedtime.
Low drug exposure favors the recruitment of high affinity target receptors over lower affinity off-target receptors. Cyclobenzaprine has been shown to have high affinity for three relevant receptor sites (target sites) and is a functional antagonist at all three sites.1
As such, TNX-102 SL is believed to possess a trimodal mechanism of action which may be beneficial in addressing disorders in which sleep disturbances play a central role. In addition, TNX-102 SL is being developed for long-term use, in contrast to oral formulations of cyclobenzaprine which are only approved for 2-3 weeks of daily use. The proposed registration plan for TNX-102 SL for PTSD, agreed to by the FDA, does not require further assessment of abuse and drug dependency potential in clinical or nonclinical study.
Pharmacokinetic studies have shown that TNX-102 SL, after sublingual administration, is distinguished from oral formulations of cyclobenzaprine:
Sleep disturbances are frequently experienced by fibromyalgia patients, and evidence suggests that these disturbances may have a role in the chronicity and exacerbation of fibromyalgia Therapies designed to treat sleep disturbances may therefore offer a unique approach to the overall treatment of fibromyalgia symptoms.
Results from earlier clinical trials have provided evidence that TNX-102 SL improves sleep quality in fibromyalgia, another disorder characterized by poor sleep quality.9
TNX-102 SL is covered by a number of issued and pending worldwide patents which cover the eutectic composition of matter, method of use, and pharmacokinetic profile. These patents are owned outright by Tonix Pharmaceuticals, and no obligations are owed to another party.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.