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Tonix Pharmaceuticals Announces Successful Completion of a Fed-Fasting and Dose Proportionality Study of TNX-102 SL
Tonix Expects the Data to Satisfy Pharmacokinetic Requirements for Potential New Drug Applications for TNX-102 SL for PTSD and Fibromyalgia Lack of a Food
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":" Tonix Expects the Data to Satisfy Pharmacokinetic Requirements for Potential New Drug Applications for TNX-102 SL for PTSD and Fibromyalgia\n Lack of a Food Effect for TNX-102 SL Supports Predictability of Therapeutic Effect NEW YORK, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix), a clinical-stage biopharmaceutical company, today announced that it has completed the required fed-fasting and dose proportionality tests of TNX-102 SL in healthy volunteers to support the New Drug Application (NDA) of TNX-102 SL for the treatment of posttraumatic stress disorder (PTSD) and fibromyalgia. The preliminary results of the study showed no significant effect of a fatty meal on the rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8 mg sublingual tablets. The absence of a food effect is consistent with transmucosal absorption after sublingual administration. Oral cyclobenzaprine products approved for treating muscle spasm have significant increases in absorption with food. Food effects which change plasma drug levels can add unpredictability for patients in terms of therapeutic benefits or side effects. The study also showed the rate and extent of absorption of cyclobenzaprine increase in a dose proportional manner from 2.8 mg to 5.6 mg for TNX-102 SL. The dose proportionality observed in this study confirms an earlier study using a prototype 2.4 mg formulation. About Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix’s lead product candidate, TNX-102 SL*, is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya**) and fibromyalgia. The Phase 3 RECOVERY trial (P302) in PTSD is currently enrolling and results from an interim analysis for a potential sample size adjustment are expected in the first quarter of 2020 and topline data are expected in the second quarter of 2020 if the sample size remains the same. TNX-102 SL for PTSD has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation. Tonix has started enrollment in the Phase 3 RELIEF trial in fibromyalgia. TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD). The agitation in...