Tonix Pharmaceuticals Holding Corp, focused on developing next-generation medicines for central nervous system disorders that include fibromyalgia and post-traumatic stress disorder (PTSD), presented reports at the recent 2016 BIO International Convention in San Francisco, Calif.
The company’s President and CEO Dr. Seth Lederman, provided information that included a corporate update and overview of the company’s fibromyalgia and PTSD clinical programs.
The investigational new drug TNX-102 SL is in a randomized, double-blind, placebo-controlled, 12-week Phase 3 AFFIRM clinical trial with fibromyalgia patients. Top-line data is expected in the third quarter of 2016.
The sublingual formulation of cyclobenzaprine HCL at 2.8 mg, is designed for daily bedtime use. In fibromyalgia patients, TNX-102 SL is meant to increase the probabilities for a patient top experience a restful night because it targets mechanisms associated with disturbed sleep and nightmares.
The U.S. Food and Drug Administration (FDA) has conditionally accepted the suggested trade name Tonmya for the drug candidate (cyclobenzaprine HCL sublingual tablets) at 2.8 mg for fibromyalgia.
The company also presented positive data from its randomized, double-blind, placebo-controlled Phase 2 AtEase clinical trial evaluating TNX-102 SL to treat military-related PTSD.
The same TNX-102 SL cyclobenzaprine HCL tablet is being developed for PTSD but at a higher concentration 5.6 mg daily bedtime dose. In the AtEase trial, the drug candidate showed efficacy (reduction in CAPS-5 score) and safety for the treatment of PTSD versus placebo.
Like fibromyalgia patients, PTSD patients report common sleep disorders and restless nights. It is believed that restoring deeper stages of sleep for PTSD patients may allow the body’s natural recovery processes from severe trauma to be established, leading to the recovery of daytime symptoms of intrusion, pathological avoidance and agitation.