TNX-105
PTSD is a psychiatric disorder that begins in the aftermath of traumatic experiences. Sleep disturbances, including nightmares and insomnia, are core features of PTSD and are included in two of the three main symptom clusters.
Patients with PTSD may have any single or combination of symptoms that include re-experiencing, emotional numbing and avoidance, and hyperarousal reactions that persist for more than one month after the traumatic event.
A number of similarities have been noted between fibromyalgia syndrome (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). Our PTSD product candidate contains cyclobenzaprine and will be formulated to optimize its release of medicine for bedtime dosing.
The rationale for studying TNX-105 in PTSD is derived from the following two core findings:
- Fibromyalgia syndrome has significant overlap with PTSD; and
- Cyclobenzaprine binds avidly to serotonin receptor type 2a (5HT2a) and blocks serotonin signaling. Clinical data suggests that other compounds that block 5HT2a signaling may be effective in the treatment of PTSD.
TONIX plans to conduct exploratory clinical studies to establish the effective dose range for our novel formulation in the treatment of PTSD symptoms. The Company will need to conduct efficacy studies before our products can be marketed as a treatment for FM or PTSD.