TherapeuticsMD Inc (NASDAQ:TXMD) has resubmitted the NDA for TX-004HR targeting moderate-to-grave vaginal pain during dyspareunia, a symptom of VVA due to menopause, with the U.S. FDA. The firm projects to learn of the NDA resubmission acceptance within 30 calendar days. The U.S. FDA will categorize the NDA resubmission as Class I or Class II upon approval of the resubmission. A Class I assessment comprises a two-month assessment from the resubmission date and a Class II assessment comprises a six-month assessment from the date of resubmission.
TherapeuticsMD marks as an innovative healthcare firm focused on commercializing and developing products solely for women. With its SYMBODA™ know-how, the company is advancing state-of-the-art advanced hormone therapy pharmaceutical offerings to allow delivery of bio-identical hormones via a variety of administration routes and dosage forms.
The firm’s late stage clinical pipeline comprises two phase III product candidates: TX-001HR for cure of moderate-to-severe VMS due to menopause; TX-004HR targeting moderate-to-grave vaginal pain during dyspareunia; and an indication of vulvar and vaginal atrophy due to menopause. It also distributes and manufactures generic and branded prescription prenatal vitamins under the BocaGreenMD® and vitaMedMD® brands.
For Q3 2017, net revenue from TherapeuticsMD’s prescription prenatal vitamin operation was around $4.4 million versus net revenue of around $5.5 million for the comparable year’s quarter. These changes were mainly due to a drop in the average net sales rate of their products and a slight drop in the count of units sold. Cost of goods sold came at around $0.7 million for Q3 2017, versus around $1.2 million for the comparable quarter, a year ago.
TherapeuticsMD reported that total operating expenses included R&D expenses and SG&A. R&D expenses for Q3 2017 came at around $6.4 million versus around $14.7 million for the same quarter, a year ago. This drop in R&D expenses was an outcome of the completion of the REPLENISH study for TX-001HR.