TherapeuticsMD Inc. submitted a new drug application to the U.S. Food and Drug Administration for TX-001HR to treat moderate-to-severe vasomotor symptoms, or hot flashes and night sweats, due to menopause.
The treatment is a bio-identical hormone therapy combination of estradiol and progesterone in an oral softgel. Vasomotor symptoms arising from menopause include night sweats, hot flashes and flushes.
The submission is supported by positive results from the phase 3 Replenish trial of TX-001HR. TherapeuticsMD expects to hear back from the FDA about 74 days after the application's submission.