Despite TherapeuticsMD’s (NYSEMKT:TXMD) FDA Complete Response Letter (CRL) for its TX-004HR (estradiol vaginal capsule) for postmenopausal dyspareunia, it still runs a good chance of approval for its lower doses without an extra, postmarketing 12-month study, experts said. If the study is done, it could be open-label, and is expected to show an excellent safety profile via endometrial biopsies, they said.
A source familiar said the CRL may be linked to TherapeuticsMD’s alleged request to remove the standard black box warning applied to oestrogen products. Experts said the two lowest doses of TX-004HR will likely be approved if resubmitted immediately with acceptance of the black box.
Experts added the postmarketing trial could be an opportunity to expand TX-004HR’s label.