Tonix Pharmaceuticals announced enrollment in the Phase 3 RECOVERY study of Tonmya, also known as TNX-102 SL (cyclobenzaprine HCl sublingual tablets) will be stopped. The study is evaluating Tonmya 5.6 mg for the treatment of posttraumatic stress disorder (PTSD). The decision to stop enrollment was made following an unblinded, pre-specified interim analysis by the Independent Data Monitoring Committee (IDMC). Based on interim analysis results of the first 50% of enrolled participants, the IDMC recommended stopping the trial for futility as Tonmya is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall 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 Tonmya and those receiving placebo. Preliminary blinded safety data from these participants did not reveal any serious and/or unexpected adverse events. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data to determine the next steps in this program. Topline results are expected in the second quarter of 2020.
The Company is reallocating resources from the PTSD program to the Phase 3 fibromyalgia study of TNX-102 SL 5.6 mg. This study is currently enrolling patients and interim results are expected in the third quarter.
About Tonmya (TNX-102 SL [cyclobenzaprine HCl sublingual tablets])
Tonmya is a sublingual transmucosal tablet formulation of cyclobenzaprine.
About Posttraumatic Stress Disorder (PTSD)
PTSD can develop from witnessing or experiencing a traumatic event in which there was the severe threat of, or actual occurrence of, grave physical harm or death. PTSD affects approximately 12 million Americans and is a chronic and severely debilitating condition in which patients re-experience the horrific traumas that resulted in the condition in the forms of intrusive memories, flashbacks, and nightmares. PTSD typically is characterized by disrupted sleep, anxiety, agitation, avoidance, emotional numbness and estrangement from family and friends, guilt or negative beliefs about self, and sometimes is associated with clinical depression and suicidal thinking. Individuals who suffer from PTSD usually have significant impairment in social functioning, occupational disability, and an overall poor quality of life. PTSD is sometimes associated with substance abuse and unpredictable violent or suicidal behaviors.