TONIX is developing TNX-102 SL as a sublingual (SL) or under-the-tongue tablet (TNX-102 SL) at a novel dose. The TNX-102 SL tablet is based on novel technology that rapidly delivers cyclobenzaprine into the body. The tablet quickly dissolves and releases cyclobenzaprine under the tongue, which is absorbed across the mucous membrane into the patient’s bloodstream. The rapid absorption of TNX-102 SL is due to the tablet’s proprietary design and formula. Patients cannot get the same rapid absorption simply by crushing existing cyclobenzaprine products and placing the powder under their tongues. cyclobenzaprine is a widely prescribed muscle relaxant with an established safety profile. Several large clinical studies have confirmed cyclobenzaprine’s safety and tolerability.
TNX-102 SL is being developed as a treatment for PTSD. andlike FM, is a disorder in which non-restorative sleep leads to next day symptoms including pain. TONIX believes that by increasing restorative sleep, TNX-102 SL can make a meaningful difference in the next day symptoms experienced by PTSD patients.
A number of similarities have been noted between FM and PTSD. For example, in a survey of FM patients, 57% of the sample had symptoms associated with PTSD (Cohen, Neumann et al. 2002). The rationale for studying TNX-102 SL in PTSD is supported by the following two core findings:
TONIX expects TNX-102 SL to have an improved tolerability and efficacy profile versus currently available generic cyclobenzaprine products. The unique qualities of TNX-102 SL provide for rapid absorption into the bloodstream and rapid excretion from the system. This is ideal for a bedtime medicine to reduce next day somnolence. In addition, since TNX-102 SL avoids first-pass metabolism by the liver, a psychoactive metabolite of cyclobenzaprine, norcyclobenzaprine, is not generated. TONIX believes that this metabolite contributes to reduced long term efficacy with the off-label chronic use of generic cyclobenzaprine.
Tonix expects to enter a Phase 2 trial of TNX-102 SL for the treatment of PTSD in 2014.