---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-045515"
form_type: "8-K"
ticker: "DARE"
cik: "0001401914"
company_name: "Dare Bioscience, Inc."
filed_at: "2023-12-20T23:59:59+00:00"
generated_at: "2026-06-07T09:46:09.802325+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Dare Bioscience reports positive Phase 1 topline results for DARE-PDM1 in primary dysmenorrhea

## Summary
- DARE-PDM1 (vaginal diclofenac hydrogel) was well-tolerated; no serious AEs; 85% of AEs mild.
- Vaginal fluid PK showed dose proportionality and retention in vaginal canal for 24 hours.
- Exploratory efficacy: statistically significant reduction in pelvic/vaginal and lower back pain for 1% DARE-PDM1 vs placebo.
- Plasma PK data pending; company plans continued development and 505(b)(2) regulatory pathway.
- DARE-PDM1 has potential as first-in-category vaginal treatment for primary dysmenorrhea; market estimated $13B in 2022.

## SEC filing metadata
- accession: 0001493152-23-045515
- form_type: 8-K
- ticker: DARE
- cik: 0001401914
- company_name: Dare Bioscience, Inc.
- filed_at: 2023-12-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401914/000149315223045515/0001493152-23-045515-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401914/000149315223045515/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-045515
- JSON: https://secwatch.observer/filing/0001493152-23-045515.json
- Plain text: https://secwatch.observer/filing/0001493152-23-045515.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.