Tonix Pharmaceuticals has reported positive results from a Phase ll, dose-finding clinical trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to treat military-related post-traumatic stress disorder (PTSD).
PTSD affects around 8.4 million Americans in any year and can develop from witnessing or experiencing a traumatic event, in which there was the severe threat or actual occurrence of grave physical harm.
The Phase ll trial, AtEase Study, was a randomised, placebo-controlled study that included 231 patients with PTSD.
Conducted at 24 clinical sites in the US, the trial compared a bedtime sublingual dose of 2.8mg TNX-102 SL or 5.6mg TNX-102 SL with placebo to treat military-related PTSD.
The retention rates were reported to be 79% on TNX-102 SL 2.8mg, 84% on TNX-102 SL 5.6mg, and 73% on placebo.
The trials' primary efficacy endpoint was the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the clinician-administered PTSD Scale for DSM-5 (CAPS-5), between those treated with TNX-102 SL 2.8mg and those receiving placebo.
Tonix noted that the CAPS-5 is a standardised, structured clinical interview and serves as the gold standard in research to assess the symptom severity of PTSD.
The company's investigational drug TNX-102 SL is waiting to be approved for indication and designed to deliver cyclobenzaprine to the bloodstream rapidly through sublingual (under the tongue) absorption, as well as bypass first-pass hepatic metabolism.
As a multifunctional agent with adversary activities at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors, TNX-102 SL is currently under clinical development to treat PTSD and is expected to provide a broad range of improvement by targeting sleep and hyperarousal.
Tonix is developing TNX-102 SL 2.8mg for daily bedtime administration to treat fibromyalgia and TNX-102 SL 5.6mg for daily bedtime administration to treat PTSD.