Tonix Pharmaceuticals is currently enrolling participants in a Phase 3 trial for military-related posttraumatic stress disorder. For more information, please visit www.thehonorstudy.com or www.clinicaltrials.gov (NCT03062540).
Tonix is developing innovative pharmaceutical products to address public health challenges, with two therapeutic programs focusing on posttraumatic stress disorder (PTSD). TNX-102 SL or Tonmya® is Tonix's lead product candidate, designed as a bedtime treatment for PTSD, is currently in Phase 3 study in the military-related PTSD population. TNX-601 (tianeptine oxalate), designed as a daytime treatment for PTSD, is in preclinical development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD and overall high utilization of healthcare services creating significant economic burden. Other products in development include TNX-801, a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing vaccine.
The proposed trade name Tonmya (ton-MY-ah), for TNX-102 SL for the management of PTSD, has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
The development of TNX-102 SL in PTSD is supported by both clinical and mechanistic rationales. In May 2016, Tonix announced positive topline results from a Phase 2 study, referred to as AtEase, investigating the efficacy and safety of bedtime TNX-102 SL 2.8 mg and 5.6 mg in military-related PTSD. To obtain FDA agreement on the Phase 3 program and the proposed New Drug Application (NDA) plan, Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA in the third quarter of 2016. In December 2016, TNX-102 SL for the treatment of PTSD was granted Breakthrough Therapy designation by the FDA based on the AtEase data. Tonix began enrolling participants into its first Phase 3 trial, the HONOR study, in the first quarter of 2017 after receiving FDA agreement on the study design and interim analysis plan.
Tonix's other PTSD program, TNX-601, is an oral formulation of tianeptine oxalate, designed as a daytime treatment for PTSD. Tianeptine oxalate is a novel polymorph and salt discovered and characterized by Tonix to improve stability and manufacturability. Tianeptine sodium (amorphous) is not approved in the US but marketed for depression in Europe, Asia, Latin America - first approved in France in 1987. The clinical development of TNX-601 for PTSD can leverage the post-marketing experience of tianeptine outside the U.S and Tonix's significant clinical and regulatory experience in PTSD.
Other Development Programs
TNX-801 is potential smallpox preventing vaccine containing a live synthetic version of horsepox virus. Since TNX-801, a biological product, will be developed for a "serious or life-threatening condition caused by exposure to lethal or permanently disabling toxic biological" , Tonix believes the "Animal Efficacy Rule" is applicable. The Animal Efficacy Rule ("Animal Rule"), a regulation which permits the licensure of a biological product based on safety testing in humans and efficacy testing in animals. In addition, the licensure of TNX-801 may be qualified for Priority Review Voucher under the Medical Countermeasure (MCM) incentive provided by the 21st Century Cures Act.
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TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication. Tonmya(R) has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL for the treatment of PTSD.