FDA clears phase 2 study of nasal spray for chronic migraine relief

The FDA has cleared an investigational new drug application for the start of a phase 2 study of TNX-1900, a nasal spray created to prevent migraine headaches.

The spray, which consists of aerosolized oxytocin, was developed by Tonix Pharmaceuticals Holding Corp., a clinical stage biopharmaceutical company.

“We are excited to have received the FDA’s [investigational new drug application (IND)] clearance to begin clinical trials for TNX-1900 in prevention of migraine headaches in chronic migraineurs,” Seth Lederman, MD, president and CEO of Tonix, said in the release. “An estimated 4 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,” Lederman added. “TNX-1900 contains magnesium, which potentiates the action of oxytocin at oxytocin receptors in animal models.”

Lederman also said he expects the company to commence the study by the end of next year. He added that the organization expressed a desire to develop the spray for patients looking to alleviate pain in the head and facial areas, as well as to address insulin resistance.