Tonix Pharmaceuticals Posted Results from Pharmacokinetic Analyses of TNX-102 SL and TNX-601 CR in Advance of Virtual Poster Presentations at the American Society of Clinical Psychopharmacology
NEW YORK, May 21, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, posted two posters for the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting to be held online virtually on May 29-30, 2020. The posters can be found on the Scientific Presentations page of Tonix’s website.
A poster, titled “Pharmacokinetic Results of Dose Proportionality and Food Effect Study of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL)” includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD). Sixteen healthy subjects, ages 18-65, were randomized in a 3-way crossover to receive a single dose of TNX-102 SL 2.8 mg fasted, TNX-102 SL 5.6 mg fasted, and TNX-102 SL 5.6 mg fed using a standardized high-fat meal.
A poster, titled “Phase 1 Pharmacokinetic Study of a Once-Daily Formulation of TNX-601 CR (Tianeptine Oxalate Controlled-Release) Tablets,” includes PK analyses of TNX-601 CR which is being developed as a once-daily treatment of major depressive disorder (MDD), PTSD and corticosteroid-induced cognitive dysfunction. In this single-center, open-label, multiple sequential period study, a single cohort of 12 male and female healthy volunteers were administered in successive periods: tianeptine sodium 12.5 mg (Stablon®1), tianeptine oxalate 13.1 mg (TNX-601), tianeptine oxalate CR (TNX-601 CR) 39.4 mg in a fasted state; and TNX-601 CR in a fed state using a standardized high-fat meal.
Dr. Gregory Sullivan, Chief Medical Officer of Tonix said, “Based on the PK results of the study with TNX-102 SL, the rate and extent of absorption of CBP increased in a dose-proportional manner from 2.8 mg to 5.6 mg of CBP. No food effect was observed for CBP for TNX-102 SL 5.6 mg. The absence of a food effect is consistent with transmucosal absorption after sublingual administration, and this is expected to provide more predictable plasma levels compared to oral swallowed forms of CBP.”
Dr. Sullivan continued, “Based on the PK results of the TNX-601 CR study, TNX-601 CR 39.4 mg demonstrated PK appropriate for once-daily dosing with minimal food effect. TNX-601 CR was well-tolerated, without unexpected side effects, and with profiles consistent with the ex-U.S.-marketed sodium salt form of tianeptine dosed three times a day. We believe these findings support further development of TNX-601 CR, the once-daily formulation of tianeptine, in MDD, PTSD and corticosteroid-induced cognitive dysfunction.”
1Stablon is a registered trademark of Les Laboratoires SERVIER (France).