NDAVAGINALINSERT
Approved
Nov 2016
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
INTRAROSA (prasterone) by Millicent Pharma is 12. Approved for postmenopausal vulvovaginal atrophy. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INTRAROSA (prasterone) is a vaginal insert containing an inactive endogenous steroid that is metabolized into active androgens and estrogens to treat postmenopausal vulvovaginal atrophy. The drug works through local vaginal delivery to restore hormone levels and alleviate symptoms of vulvar and vaginal atrophy. It represents a novel hormone replacement approach using a patient-friendly vaginal insert formulation.
$37KPart D
Peak4.9 years to LOEINTRAROSA occupies a niche gynecological segment with minimal Part D penetration, suggesting a small specialized brand team focused on patient education and healthcare provider relationships.
Mechanism of Action
12.1 Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established. 12.3 Pharmacokinetics In a study conducted in…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.