Tonix Pharmaceuticals (US:TNXP)2019-10-29 10:51TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) - TNX-102 SL is in Phase 3 development for Bedtime Treatment for PTSD (Tonmya®) and Fibromyalgia, and Phase 2 ready for Bedtime Treatment for Agitation in Alzheimer's [7] - TNX-102 SL is also in Pre-IND stage for Bedtime Treatment for Alcohol Use Disorder (AUD) [7] - TNX-102 SL's intellectual property is expected to have U S protection until 2035 [18] - A Phase 2 study showed that 21.10% of patients in the TNX-102 SL 5.6 mg group achieved remission at Weeks 8 & 12, compared to 5.20% in the placebo group [34] - AEs in P201/AtEase and P301/HONOR Studies showed that 38.7% and 37.3% of patients in the TNX 5.6 mg group experienced Hypoaesthesia oral, respectively [41] - A new Phase 3 P302/RECOVERY Study for TNX-102 SL in PTSD was initiated in 1Q 2019 [43] Other Pipeline Products - TNX-1300 (Cocaine esterase) is in Mid-Phase 2 development for Cocaine intoxication [101] - TNX-601 (Tianeptine oxalate oral formulation) is in Phase 1 formulation development for Daytime Treatment for PTSD [7, 101] - TNX-801 (Live horsepox virus (HPXV) vaccine from cell culture) is in Pre-clinical development for Smallpox-preventing vaccine [14, 101] - An estimated 16 million people in the U S have AUD [55] - Approximately 21% of all emergency department (ED) visits involve cocaine [71]