Tonix Pharmaceuticals Moves TNX-1900 into Phase 2 Studies After FDA Clearance

Tonix Pharmaceuticals Holding Corp. has announced the successful FDA clearance of their investigational new drug (IND) for Potentiated Intranasal Oxytocin (TNX-1900). The treatment can be used to prevent migraine headaches for those chronically afflicted.

Tonix is a clinical-stage biopharmaceutical company based in New Jersey who has spent their time repurposing drugs for central nervous system conditions. 

The FDA clearance will allow TNX-1900 to be pushed into a Phase 2 study. The study is expected to qualify for the 505(b)(2) pathway for full FDA approval – a pathway available only to new formulations of an approved drug.

Migraines are a symptom of a neurological condition which manifests in throbbing headaches, light auras, and aversions to lights, smells, and noises. Tonix believes that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 could prevent migraines. The drug contains magnesium which potentiates the action of oxytocin at oxytocin receptors in animal models. 

Oxytocin is a naturally occurring human hormone with no recognized addiction potential. It has been observed that lowered oxytocin levels in the body can lead to increased migraine headache frequency. Some other chronic pain conditions are also associated with low oxytocin levels.

Tonix has further plans to develop TNX-1900 for craniofacial pain and insulin resistance.

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