Introduction to Intrarosa
Intrarosa, also known as prasterone or dehydroepiandrosterone (DHEA), is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe pain during sexual intercourse (dyspareunia) in postmenopausal women. This condition is a symptom of vulvar and vaginal atrophy (VVA) caused by the decline in estrogen levels during menopause[1][2][4].
Clinical Trials and Efficacy
Primary Efficacy Results
The efficacy of Intrarosa was established through several clinical trials. Two 12-week placebo-controlled clinical trials involving 406 postmenopausal women demonstrated that Intrarosa significantly reduced the severity of pain during sexual intercourse. These trials showed that women who received Intrarosa experienced a statistically significant decrease in pain compared to those who received a placebo[1][4].
Long-Term Efficacy
A 52-week non-comparative, open-label clinical trial involving 183 postmenopausal women further supported the long-term efficacy of Intrarosa. This study showed a sustained decrease in pain during sex over one year of continued daily use[4].
Additional Exploratory Findings
In addition to reducing pain, Intrarosa also showed improvements in sexual function across various areas, including desire, arousal, lubrication, satisfaction, and orgasm, although it is not indicated for the treatment of sexual dysfunction[4].
Safety Profile
Common Adverse Reactions
The safety of Intrarosa was evaluated in multiple clinical trials. The most commonly reported adverse reactions include vaginal discharge and changes in Pap smear results. In a 52-week clinical trial, vaginal discharge was reported by 14% of women, and changes in Pap smear results were reported by 2.1% of women[3][4].
Endometrial Safety
Endometrial biopsies performed after 52 weeks of Intrarosa treatment showed no evidence of hyperplasia, indicating that the drug does not pose a risk of endometrial hyperplasia[3][4].
Market Analysis
Market Need and Demand
Intrarosa addresses a significant unmet need in women’s health by providing a non-estrogen treatment option for postmenopausal women experiencing painful sex due to VVA. Given the prevalence of VVA and the discomfort it causes, there is a substantial market demand for effective treatments like Intrarosa[2].
Competitive Landscape
Intrarosa is the first FDA-approved product containing prasterone for this indication, making it a unique offering in the market. While there are other treatments for VVA, such as estrogen-based therapies, Intrarosa’s non-estrogen formulation provides an alternative for women who may not be suitable for or prefer not to use estrogen-based treatments[1][2].
Market Projections
The Femtech industry, which includes products like Intrarosa, is expected to grow significantly in the coming years. With its innovative approach and clinical proven results, Intrarosa is poised to capture a substantial share of this growing market. As more women become aware of the treatment options available for VVA, the demand for Intrarosa is likely to increase, driving market growth[2].
Regulatory Status
FDA Approval
Intrarosa was approved by the FDA in November 2016 for the treatment of moderate to severe pain during sexual intercourse in postmenopausal women with VVA[1].
International Approvals
In addition to FDA approval, Intrarosa has also been approved in other regions. For example, it was registered in Australia in June 2023, with the Therapeutic Goods Administration (TGA) requiring the inclusion of the black triangle symbol and mandatory accompanying text for five years to monitor its safety[5].
Patient Access and Affordability
Cost and Copay Programs
To improve patient access, eligible commercially insured patients can benefit from a copay program that reduces the cost of Intrarosa to as little as a $35 copay for 28 vaginal inserts[4].
Conclusion
Intrarosa represents a significant advancement in the treatment of painful sex due to VVA in postmenopausal women. With its strong clinical trial data, favorable safety profile, and unique market position, Intrarosa is well-positioned for continued growth and adoption.
Key Takeaways
- Efficacy: Intrarosa has been clinically proven to reduce moderate to severe pain during sex in postmenopausal women.
- Safety: The drug has a favorable safety profile with common adverse reactions including vaginal discharge and changes in Pap smear results.
- Market Demand: There is a substantial market need for effective treatments like Intrarosa, driven by the prevalence of VVA.
- Regulatory Status: Approved by the FDA and registered in other regions, including Australia.
- Patient Access: Affordability programs are available to reduce the cost for eligible patients.
FAQs
Q: What is Intrarosa used for?
Intrarosa is used to treat moderate to severe pain during sexual intercourse (dyspareunia) in postmenopausal women, a symptom of vulvar and vaginal atrophy (VVA)[1].
Q: How does Intrarosa work?
Intrarosa works by improving the condition of vaginal tissue affected by menopause, thereby reducing pain during intercourse. It contains prasterone (DHEA) combined with coconut and palm oils[2].
Q: What are the common side effects of Intrarosa?
The most commonly reported adverse reactions to Intrarosa include vaginal discharge and changes in Pap smear results[3][4].
Q: Is Intrarosa safe for long-term use?
Clinical trials have shown that Intrarosa is safe for long-term use, with no evidence of endometrial hyperplasia after 52 weeks of treatment[3][4].
Q: How is Intrarosa administered?
Intrarosa is administered as a once-daily vaginal insert, typically at bedtime[1][4].
Sources
- FDA Press Announcement: "FDA approves Intrarosa for postmenopausal women experiencing pain during sex."
- Health IT Answers: "The Future of Femtech: 7 Trends to Watch in 2025."
- Health Canada: "Summary Basis of Decision for Intrarosa."
- Intrarosa Official Website: "Clinically Proven Results."
- Therapeutic Goods Administration (TGA): "Intrarosa."
