Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge eating disorder later this year. The Massachusetts General study is expected to enroll 60 patients with binge eating disorder and will evaluate the efficacy of TNX-1900 versus placebo in reducing bingeing frequency and body weight over 8 weeks. A Phase 2 trial of TNX-1900 for the prevention of migraine is also expected to begin in the second half of 2022.
Tonix CEO Seth Lederman said, “Binge eating disorder is a serious mental health condition associated with behavioral and metabolic morbidity for which there are few treatment options. Oxytocin is a well-known natural hormone that is used therapeutically in certain other indications including as an IV medication for the induction of labor in pregnancy with a medical indication. We are hopeful that our proprietary intranasal dosage form will enhance its properties for use in the underserved population of patients suffering from binge eating disorder.”
The other formulation, TNX-2900 for the treatment of Prader-Willi syndrome, was licensed from the French National Institute of Health and Medical Research (Inserm) in February 2021. According to the company, the FDA has now granted orphan drug designation to TNX-2900 nasal spray for the treatment of Prader-Willi syndrome (PWS). Earlier this year, the FDA issued a CRL to Levo Therapeutic’s NDA for its intranasal oxytocin for the treatment of PWS.
Lederman commented “Orphan drug designation by the FDA is an important milestone and further validates our efforts to investigate the utility of TNX-2900 for Prader-Willi syndrome. It underscores the urgent, unmet medical need for patients diagnosed with this disease, and will benefit us as we continue to advance our program.”
Read the Tonix Pharmaceuticals press release on TNX-2900.
Read the Tonix Pharmaceuticals press release on TNX-1900.
