Tonix Pharmaceuticals gets FDA clearance for TNX-1900 phase 2 trial in chronic migraineurs

Tonix Pharmaceuticals is set to launch a phase 2 clinical trial of TNX-1900 (intranasal potentiated oxytocin) in migraine patients after getting clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application.

The clinical-stage biopharma company, which is based in Chatham, New Jersey, is planning the mid-stage clinical trial to assess the investigational drug for the prevention of migraine headache in chronic migraineurs.

According to Tonix Pharmaceuticals, the phase 2 program is anticipated to qualify for the 505(b)(2) pathway for approval by the FDA. The 505(b)(2) pathway is available to new formulations of an approved drug.

Tonix Pharmaceuticals gets FDA clearance for TNX-1900 phase 2 trial in chronic migraineurs. Photo courtesy of Gerd Altmann from Pixabay .

Seth Lederman — President and CEO of Tonix Pharmaceuticals 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.”

Seth Lederman said that Tonix Pharmaceuticals anticipates to start patient enrollment in the TNX-1900 phase 2 clinical trial in the latter half of next year.

TNX-1900 is a formulation of oxytocin, which is also being developed for the treatment of craniofacial pain, insulin resistance, and associated conditions. It was acquired by Tonix Pharmaceuticals in 2020 from Trigemina and licensed from Stanford University.