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 emerging public health issues, with two programs focusing on posttraumatic stress disorder (PTSD). TNX-102 SL is ready to start Phase 3 and TNX-601 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 development efforts include a smallpox-preventing vaccine program.
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 TNX-102 SL in military-related PTSD. To prepare for the Phase 3 program and seek guidance on the 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 received Breakthrough Therapy designation by the FDA for the treatment of PTSD. Tonix plans to begin enrolling patients into its first Phase 3 study, 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 for which Tonix has discovered and characterized a novel polymorph and salt. Tianeptine sodium (amorphous) is 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.
Other Development Programs
TNX-801 is a live novel virus vaccine with the potential to prevent smallpox. Since TNX-801 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 approval of some products based on safety testing in humans and efficacy testing in animals. In addition, the approval of TNX-801 may be qualified for Priority Review Voucher under the Medical Countermeasure (MCM) incentive provided by the 21st Century Cures Act.
Our experienced team has a strong track record of success in drug development, regulatory approvals, and product launch activities.
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication.