tianeptine oxalate controlled release (TNX-601 CR) / Tonix - LARVOL DELTA

A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder. (PubMed, Drugs) - "Indeed, investigations and drug development are proceeding in a number of these alternative, non-serotonergic pathways in an effort to improve the management of PTSD. In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders."

Journal • Review • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

A Randomized Placebo-Controlled Multicenter Trial of Monotherapy with TNX-601 ER* (Tianeptine Hemioxalate Extended-Release Tablets) for Treatment of Major Depressive Disorder (MDD) (ASCP 2023) - P2 | "Learning Objectives Discuss the development of a novel antidepressant for the US market under an IND. Describe the protocol of a Phase 2b registration-quality industry trial of a new once-daily formulation of tianeptine."

Clinical • Monotherapy • Alzheimer's Disease • Anorexia • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Obsessive-Compulsive Disorder • Personality Disorder • Post-traumatic Stress Disorder • Psychiatry • Sleep Disorder • Substance Abuse

TNX-601 CR*: a once-daily formulation of tianeptine in development for the treatment of major depressive disorder in the United States (CNS SUMMIT 2021) - "The selected precursor prototype demonstrated PKs appropriate for once-daily dosing, with minimal food effect, which is a potential adherence advantage over TID tianeptine sodium. These Phase I findings in the selected precursor prototype support upcoming Phase II testing of the once-daily TNX-601 CR (controlled-release tianeptine oxalate 39.4mg and naloxone 1mg) tablet in MDD in early 2022."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Tonix Pharmaceuticals Reports Second Quarter 2021 Financial Results and Operational Highlights (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp....announced financial results for the second quarter ended June 30, 2021 and provided an overview of recent operational highlights....Based on official minutes from a pre-IND meeting with the FDA, the Company expects to initiate a Phase 2 study for the treatment of depression in the first half of 2022, pending results of nonclinical toxicology studies and IND clearance."

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder

Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA on TNX-601 CR for the Treatment of Major Depressive Disorder (GlobeNewswire) - "Tonix Pharmaceuticals...announced that it has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder (MDD)....Based on the official minutes, Tonix expects to submit the IND to conduct a human abuse potential study and meet with FDA’s controlled substances staff (CSS) to reach agreement on the details of the abuse potential study. Pending the results of the human abuse potential study and the results of ongoing nonclinical toxicology studies, Tonix expects to be in a position to initiate a Phase 2 study for the treatment of MDD in the fourth quarter of 2021."

FDA event • IND • New P2 trial • CNS Disorders • Depression • Major Depressive Disorder

Tonix Pharmaceuticals Announces Issuance of U.S. Patent for Compositions and Uses of Tianeptine Oxalate Salt, the Active Ingredient of TNX-601 CR (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp....announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,946,027 to the Company on March 16, 2021....The new patent...includes claims...comprising crystalline tianeptine oxalate salts, to methods of using those compositions to treat various disorders...This patent is expected to provide Tonix with U.S. market exclusivity until December 28, 2037, excluding any patent term extensions. Tonix’s TNX-601 CR is a novel oral formulation of one of the claimed tianeptine oxalate salts, which is being developed as a potential treatment for major depressive disorder (MDD), posttraumatic stress disorder and neurocognitive dysfunction associated with corticosteroid use."

Patent • CNS Disorders • Depression • Major Depressive Disorder • Post-traumatic Stress Disorder

[VIRTUAL] Phase 1 Pharmacokinetic Study of a Once-Daily Formulation of TNX-601 CR (Tianeptine Oxalate Controlled-Release) Tablets (ASCP 2020) - "Stablon and TNX-601 demonstrated similar PK for plasma tianeptine and MC5. For plasma tianeptine, Tmax was 1.5 hour (h) for Stablon and 1.0 h for TNX-601. Cmax, AUC0-24, and t1/2 for Stablon were 239 ng/mL, 935 ng*h/mL, and 3.13 h, and for TNX-601 were 237 ng/mL, 942 ng*h/mL, and 3.56 h, respectively."

P1 data • PK/PD data • CNS Disorders • Depression • Mood Disorders • Post-traumatic Stress Disorder

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 (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) - "Tonix Pharmaceuticals Holding Corp....posted two posters for the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting to be held online virtually on May 29-30, 2020....'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....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....We believe these findings support further development of TNX-601 CR...in MDD, PTSD and corticosteroid-induced cognitive dysfunction.'"

P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Depression • Fibromyalgia • Musculoskeletal Diseases • Pain • Post-traumatic Stress Disorder

Investor presentations: Tonix Pharmaceuticals Holding Corp (Tonix Pharma Press Release) - "TNX-601 CR (Tianeptine Oxalate Controlled Release) Tablets; Proprietary new controlled release formulation for once-daily dosing; Plan to request pre-IND meeting with FDA in 2020; Plan for Phase 2 study in depression in 2021."

IND • New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Tonix Pharmaceuticals reports fourth quarter and full year 2019 financial results and operational highlights (GlobeNewswire) - "The Company announced in the fourth quarter of 2019 the successful completion of a Phase 1 study evaluating the safety, tolerability and pharmacokinetics (PK) of controlled release (CR) formulations of TNX-601 (tianeptine oxalate). TNX-601 CR is being developed...PTSD...Tonix plans to start the first efficacy trial ex-U.S. in 2021 and request a pre-IND meeting with the FDA in 2020."

New trial • P1 data • Regulatory

Tonix Pharmaceuticals Announces Plan to Develop TNX-601 CR Tablets for Once-Daily Treatment of Major Depressive Disorder, in Addition to PTSD, After Successful Completion of Phase 1 Pharmacokinetic Study (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) - "Tonix Pharmaceuticals Holding Corp...announced that it has developed a controlled release formulation of tianeptine oxalate, TNX-601 CR....Tonix plans to develop TNX-601 CR for major depressive disorder (depression) in addition to posttraumatic stress disorder (PTSD). Tonix plans to start the first efficacy trial ex-U.S. in 2020 and request a pre-IND meeting with Food and Drug Administration (FDA) in the first half of 2020."

Clinical • Regulatory

Tonix Pharmaceuticals Reports Third Quarter 2019 Financial Results and Operational Highlights (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) - "50% of Enrollment Complete for Phase 3 RECOVERY Trial of Tonmya® for the Treatment of PTSD...Initiated a single-dose, randomized, open-label, 3-way crossover study to evaluate the dose-proportionality and food-effect of TNX-102 SL in healthy subjects (TNX-CY-F110). This study is one of the requirements to support a New Drug Application (NDA) for TNX-102 SL...Dosed healthy subjects in a Phase 1 study...of TNX-601 (tianeptine oxalate)...Data from this study are expected by the end of 2019. Expected to be Phase 2 ready for ex-US study and IND-ready in the US in 2020."

Clinical • Enrollment status • P1 data

Tonix Pharmaceuticals announces issuance of U.S. patent for crystalline tianeptine oxalate salt, the active ingredient of TNX-601 (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...announced that the U.S. Patent and Trademark Office ('USPTO') issued U.S. Patent No. 10,449,203 to the Company on October 22, 2019. This patent, 'Tianeptine Oxalate Salts and Polymorphs,' includes claims directed to crystalline tianeptine oxalate salts, and disclosures directed to methods of using those crystalline forms and their compositions. This patent...is expected to provide Tonix with U.S. market exclusivity until December 28, 2037."

Patent