Tonix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for TNX-2900 (intranasal potentiated oxytocin) to treat Prader-Willi syndrome. Prader-Willi syndrome is a rare genetic disorder that causes hyperphagia, or an overriding physiological drive to eat, in children and adults, leading to obesity and other complications related to significant mortality. TNX-2900 is intended for use by adults and adolescents, and the formulation is based on Tonix’s patented intranasal potentiated oxytocin. Presumably, it increases specificity for oxytocin receptors relative to vasopressin receptors and enhances the potency of oxytocin, which is a naturally occurring hormone that acts as a neurotransmitter in the brain. Tonix Pharmaceuticals is a clinical-stage biopharmaceutical company committed to discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease, with a focus on developing small molecules and biologics to treat central nervous system and immunological conditions.

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