> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# On 2nd Try, Vaginal Pain Drug Approved
- URL: https://www.fdaweb.com/on-2nd-try-vaginal-pain-drug-approved/
- Published: 2018-05-30T12:00:00.000Z
- Updated: 2026-09-15T00:09:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141565

FDA has approved a TherapeuticsMD NDA resubmission for Imvexxy (estradiol vaginal inserts) for treating moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, due to menopause. FDA 5/2017 rejected an earlier submission, raising concern about a lack of long-term endometrial safety data beyond the 12 weeks studied in the pivotal phase 3 Rejoice Trial, the company said at the time ([see story](https://www.fdaweb.com/fda-rejects-therapeuticsmd-nda-for-sex-pain-drug/)). The agency subsequently reversed its decision for more data before approval — a move that may signal the agency’s increasing reliance on [real world data](https://www.fdaweb.com/fda-has-drug-evidence-flexibility-califf-staff/). The NDA resubmission was permitted with the company committing to conduct a post-approval observational study

Imvexxy is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market, according to the company. Its mechanism of action is the re-estrogenization of the tissue in and around the vagina, and it is administered daily for two weeks followed by only twice a week dosing. The most common adverse reaction reported in clinical trials was headache. The approval also carries a boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.