Tonix Pharmaceuticals has started patient enrolment in the Phase III RECOVERY clinical trial of Tonmya to treat patients suffering from post-traumatic stress disorder (PTSD).
Tonmya is a small, rapidly-disintegrating therapeutic comprising of 2.8mg cyclobenzaprine HCl. It is formulated for sublingual administration in order to optimise cyclobenzaprine delivery and absorption.
The product candidate is intended to improve quality of sleep in PTSD patients.
RECOVERY is a double-blind, randomised, placebo-controlled trial being conducted to assess the safety and efficacy of 5.6mg Tonmya over 12 weeks in approximately 250 patients at around 30 US centres.
The trial will enrol people who experienced an index trauma within nine years of screening.
Primary efficacy endpoint of the trial is mean change in the severity of PTSD symptoms from baseline as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
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Tonmya will be compared to placebo in the trial, and top-line results are expected to be available in the first half of next year.
Tonix Pharmaceuticals president and CEO Seth Lederman said: “Tonix is committed to improving the lives of the millions who suffer from PTSD, especially military-related PTSD, and enrolling the first participant in the RECOVERY study is an important step towards achieving this goal.
“We believe the innovative design features of the RECOVERY study, which are based on careful analyses of data from our prior PTSD trials, in addition to FDA feedback, may increase the probability of success of the RECOVERY study.”
PTSD is a chronic and severely debilitating disorder that impacts nearly 12 million people in the US. Patients suffer from disrupted sleep, anxiety, agitation and emotional numbness, among other symptoms.