Mass General plans study of nasally delivered binge eating disorder drug

Massachusetts General Hospital is preparing to trial Tonix Pharmaceuticals’ nasally delivered potentiated oxytocin TNX-1900 in the treatment of binge eating disorder. 

Tonix is developing TNX-1900 as a treatment of chronic migraine, with a phase 2 clinical trial set to start in the indication in the second half of the year, but the delivery of the human hormone oxytocin via the nose is potentially applicable to other indications.

Elizabeth Lawson, M.D., director of the interdisciplinary oxytocin research program at Massachusetts General Hospital’s neuroendocrine unit, set out the rationale for running a phase 2 clinical trial of TNX-1900 in the treatment of binge eating disorder.

“While available psychological and pharmacological treatments produce remission from binge eating in some cases, up to 50% of patients continue to binge, and weight loss in those with obesity is difficult to achieve and sustain. There is accumulating evidence that oxytocin may reduce food intake by acting on neural pathways involved in reward and impulse control, which have been implicated in binge eating disorder,” Lawson, the principal investigator of the trial, said in a statement.

Lawson’s previous work has suggested giving oxytocin via the nose may reduce food intake, enhance eating impulse control and modulate the neural circuitry that drives eating behavior. The investigator-initiated binge eating disorder clinical trial is expected to start in the second half of the year.

The eight-week clinical trial is set to randomize 60 patients with binge eating disorder and obesity to take either TNX-1900 or placebo. In doing so, Lawson and her collaborators aim to determine whether TNX-1900 reduces binging frequency and body weight.