Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced that the FDA has cleared its Investigational New Drug Application supporting the commencement of the second phase trial of TNX-1900 for migraine prevention in chronic migraineurs. Notably, the program will likely qualify for the 505(b)(2) pathway for approval that is accessible to a new formulation of an already approved treatment.
Tonix receives IND clearance for TNX-1900
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.”
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.”
Tonix acquired TNX-1900 in 2020
TNX-1900 is intranasal potentiated oxytocin, a patented oxytocin formulation. Tonix is developing as chronic migraine prevention and therapy candidate and insulin resistance, craniofacial pain, and other diseases. The company acquired TNX-1900 from Trigemina, Inc. in 2020 and was licensed by Stanford University. Oxytocin is a neurotransmitter in the brain that is produced spontaneously by humans. Interestingly it has no known potential for addiction. Low oxytocin levels in the body have been linked to an increased migraine headache frequency, whereas increasing oxytocin levels have been linked to migraine headache relief.
Migraine is a neural illness that causes a pounding headache that lasts up to four hours, usually on one side of the head. All possible symptoms are nausea, vomiting, sensitivity to bright light and visual abnormalities, strong smells, and loud noises. According to epidemiological studies, roughly 1.2 billion people worldwide suffer from migraines each year.