Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application to support the initiation of a Phase 2 study of TNX-1900* (intranasal potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs. The program is expected to qualify for the 505(b)(2) pathway for FDA approval, which is available to new formulations of an approved drug.

“We are excited to have received the FDA’s IND clearance to begin clinical trials for TNX-1900 in prevention of migraine headaches in chronic migraineurs,” said Seth Lederman, M.D., President and CEO of Tonix. “An estimated four million individuals in the United States suffer from chronic migraine. We believe that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help chronic migraine sufferers. TNX-1900 contains magnesium, which potentiates the action of oxytocin at oxytocin receptors in animal models. We expect to begin enrollment in the TNX-1900 Phase 2 study in the second half of 2022.”

Dr Lederman added, “We also plan to develop TNX-1900 for craniofacial pain as well as insulin resistance. A related intranasal potentiated oxytocin product candidate, TNX-2900*, is under development for the treatment of Prader-Willi syndrome.”