This article is more than 5 years old. Information may no longer be current.
Retrospective analysis reaffirms efficacy of TNX-102 for PTSD
Tonix Pharmaceuticals recently presented retrospective data that indicated TNX-102 SL significantly improved sustained remission in PTSD.
In May 2016, phase 2 findings indicated efficacy of TNX-102 SL for military-related PTSD.
The phase 2 study was a multicenter, 12-week, double blind placebo-controlled study conducted among 231 individuals who experienced trauma during military service since 2001, had moderate PTSD severity and were free of antidepressants for at least 2 months. Study participants were randomized to receive 2.8 mg (n = 90) or 5.6 mg (n = 49) of TNX-102 SL or placebo (n = 92) sublingually at bedtime.
Both dosage groups had significantly greater mean changes in the arousal and reactivity cluster of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), compared with placebo. This association occurred at weeks 2, 4 and 8 among participants who received 2.8 mg of TNX-102 SL and at weeks 2, 8 and 12 among those who received 5.6 mg.
At week 12, participants who received 5.6 mg of TNX-102 SL had significantly greater response on the Clinical Global Impression-Improvement (CGI-I) scale.
The recently presented retrospective analysis indicated the 5.6-mg dosage had an effect size of approximately 0.5 on total CAPS-5 and approximately 0.5 on cluster B (intrusion) and cluster E (arousal and reactivity) scores.
Further, the 5.6-mg dosage significantly increased sustained remission, compared with placebo.
Nondose-related tongue numbness was commonly reported among participants receiving either dosage of TNX-102 SL.
There were no discontinuations due to adverse events among participants who received 5.6 mg of TNX-102 SL.
The HONOR study, a phase 3, 12-week, randomized, double-blind, placebo-controlled trial is currently being conducted to assess efficacy of 5.6 mg of TNX-102 SL for military-related PTSD. Targeted enrollment is 550 participants across 35 clinical sites.
An unblended interim analysis will be conducted once efficacy data has been collected from 275 randomized participants, according to a company press release.
“We continue to work with the FDA to accelerate the development and registration of TNX-102 SL for PTSD,” Seth Lederman, MD, president and CEO of Tonix, said in the release. “Our Phase 3 HONOR study is currently enrolling participants with military-related PTSD. A planned unblinded interim analysis on 50% of the randomized participants (n = 275) is on track for the first half of 2018.”
Reference:
Low-dose bedtime sublingual cyclobenzaprine (TNX-102 SL) for the treatment of military-related PTSD: Retrospective analyses of the mediators and moderators of treatment response. Presented at: American Society of Clinical Psychopharmacology Annual Meeting. May 29-June 2, 2017; Miami Beach, Fla.