Oestradiol refiled with FDA for vaginal pain due to menopause

The company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, with the U.S. Food and Drug Administration (FDA).

The Company expects to learn of the acceptance of the NDA resubmission within 30 calendar days. The FDA will classify the NDA resubmission as Class 1 or Class 2 upon acceptance of the resubmission. A Class 1 review constitutes a two-month review from the date of resubmission and a Class 2 review constitutes a six-month review from the date of resubmission.

Comment: TX-004HR is a 17? estradiol product under development for treatment of postmenopausal women for vulvar and vaginal atrophy. It is a unique delivery design using a VagiCap softgel capsule technology to provide easy, simple delivery.