FDA Clears Tonix Pharma's Human Trial With Intranasal Oxytocin For Migraine

The FDA has signed off Tonix Pharmaceuticals Holding Corp's TNXP Investigational New Drug (IND) Application to initiate Phase 2 study of TNX-1900 for migraine.

•  TNX-1900 is intranasal potentiated oxytocin designed for the prevention of migraine headaches in chronic migraineurs. 
• The program is expected to qualify for the 505(b)(2) pathway for FDA approval, available to new formulations of an approved drug.
• Oxytocin, also known as the cuddle hormone, plays a significant role in social interactions and social bonding.
• TNX-1900 contains magnesium, which potentiates the action of oxytocin at oxytocin receptors in animal models. 
• The Company plans to begin enrollment in the TNX-1900 Phase 2 study in 2H of 2022.
• It also plans to develop TNX-1900 for craniofacial pain and insulin resistance. A related intranasal potentiated oxytocin product candidate, TNX-2900, is under development for Prader-Willi syndrome, a genetic disorder characterized by constant hunger.
• Related content: Benzinga's Full FDA Calendar.
• Price Action: TNXP shares are up 22.40% at $0.57 during the premarket session on the last check Tuesday.