According to Tonix Pharmaceuticals, the FDA has cleared the company’s IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal oxytocin for the treatment of migraine from Trigemina in June 2020 and says that it would plan to submit an NDA under the 505(b)(2) pathway. Over the past year, the company also licensed intranasal oxytocin for insulin resistance, obesity, and Prader-Willi syndrome.
Tonix Pharmaceuticals President and CEO Seth Lederman said, “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. 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. 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.”
Read the Tonix Pharmaceuticals press release.
