Introduction
Annovera, a combined hormonal contraceptive vaginal system containing segesterone acetate and ethinyl estradiol, was approved by the FDA in August 2018. This innovative contraceptive offers a unique combination of convenience, efficacy, and user control, making it an attractive option in the contraceptive market.
Market Potential
The market for contraceptives is significant, driven by the need for effective and convenient methods to prevent pregnancy. Annovera fills a niche by providing a long-lasting, user-controlled hormonal contraceptive that does not require daily administration or special storage conditions. This convenience is particularly appealing, as it addresses the issue of inconsistent or incorrect use of contraceptives, which is a common reason for unintended pregnancies[1].
User Experience and Acceptance
Clinical trials and post-marketing data indicate that Annovera is well-accepted by users. The vaginal ring is inserted for 21 days and removed for 7 days each cycle, and the same ring can be used for up to 13 cycles (one year). This regimen is associated with a highly favorable and consistent bleeding pattern, leading to very low discontinuation rates[3].
Efficacy and Safety
Annovera has demonstrated efficacy comparable to other combined hormonal contraceptives. The pooled efficacy data from Phase 3 studies showed a pregnancy incidence (PI) of 2.98 per 100 woman-years, which is within the range of other recently approved products for the same indication[1].
However, like other combination hormonal contraceptives, Annovera carries a risk of venous thromboembolism (VTE). The estimated rate of VTE for Annovera was higher than some other combination hormonal contraceptives, with 24 cases per 10,000 woman-years, although this estimate is associated with a wide confidence interval indicating uncertainty. Further postmarketing studies are planned to evaluate this risk more thoroughly[5].
Financial Performance
Since its launch, Annovera has shown promising financial performance, although it has faced some challenges.
Revenue
In the third quarter of 2022, Annovera generated net product revenue of $10.4 million, which was a decrease from $11.8 million in the third quarter of 2021. Despite this, the total prescriptions for Annovera grew by 10% compared to the third quarter of 2021[2].
Prescription Trends
Approximately 9,200 Annovera prescriptions were dispensed to patients during the third quarter of 2022. Over 15,000 healthcare providers have prescribed Annovera since its launch, with more than 1,500 new prescribers added in the third quarter of 2022 alone[2].
Market Adoption
The product has been adopted by a significant number of healthcare providers and patients. The growth in prescriptions and the expansion of the prescriber base indicate a positive market reception. However, the company has had to navigate inventory issues and other operational challenges, which have impacted revenue in some quarters[2].
Competitive Landscape
Annovera is the second FDA-approved combination hormonal vaginal ring contraceptive in the U.S., following the etonogestrel/ethinyl estradiol ring (Nuvaring, Eluryng, and equivalents). The unique selling point of Annovera is its long-lasting use – one ring can be used for up to a year without the need for refrigeration prior to dispensing, which adds to its convenience and user appeal[3][5].
Future Outlook
Despite some initial challenges, the market dynamics suggest a promising future for Annovera. The convenience, efficacy, and user-controlled nature of the product are likely to continue attracting users. However, ongoing monitoring of the VTE risk and further postmarketing studies will be crucial in maintaining and enhancing its market position.
Postmarketing Commitments
The FDA has required postmarketing studies to further evaluate the risk of VTE associated with Annovera, particularly in women with a BMI >29 kg/m². These studies will help in refining the safety profile and potentially expanding the product's use in different populations[5].
Market Expansion
With the wholesale network now fully stocked and inventory issues resolved, TherapeuticsMD, the company behind Annovera, is well-positioned to continue growing its market share. The addition of new prescribers and the stable prescription trends indicate a strong foundation for future growth[2].
Key Takeaways
- Convenience and Efficacy: Annovera offers a convenient, long-lasting, and user-controlled hormonal contraceptive option.
- Market Adoption: The product has been well-received by healthcare providers and patients, with growing prescription trends.
- Financial Performance: Despite some revenue fluctuations, Annovera has shown promising financial performance and growth potential.
- Safety Monitoring: Ongoing postmarketing studies are crucial for refining the safety profile, particularly regarding VTE risk.
- Competitive Advantage: Annovera's unique features, such as its long-lasting use and lack of need for refrigeration, differentiate it in the market.
FAQs
Q: What is Annovera, and how is it used?
A: Annovera is a combined hormonal contraceptive vaginal system containing segesterone acetate and ethinyl estradiol. It is inserted vaginally for 21 days and removed for 7 days each cycle, with the same ring usable for up to 13 cycles (one year)[1].
Q: How effective is Annovera in preventing pregnancy?
A: Annovera has demonstrated an efficacy comparable to other combined hormonal contraceptives, with a pregnancy incidence of 2.98 per 100 woman-years[1].
Q: What are the potential risks associated with Annovera?
A: Like other combination hormonal contraceptives, Annovera carries a risk of venous thromboembolism (VTE). The estimated rate of VTE for Annovera is higher than some other products, and further postmarketing studies are planned to evaluate this risk[5].
Q: How has Annovera performed financially since its launch?
A: Annovera generated $10.4 million in net product revenue in the third quarter of 2022, with a 10% growth in prescriptions compared to the third quarter of 2021. Despite some revenue fluctuations, the product has shown promising financial performance and growth potential[2].
Q: What are the unique selling points of Annovera compared to other contraceptives?
A: Annovera's unique features include its long-lasting use (up to one year without replacement), lack of need for refrigeration prior to dispensing, and a convenient dosing regimen that does not require daily administration[1][3].
Sources
- FDA Multi-disciplinary Review and Evaluation: Annovera - accessdata.fda.gov
- TherapeuticsMD Announces Third Quarter 2022 Financial Results - ir.therapeuticsmd.com
- A Technology Evaluation of Annovera - ohsu.elsevierpure.com
- NDA/BLA Multi-disciplinary Review and Evaluation: Annovera - fda.gov
- Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal Ring (Annovera) - va.gov/formularyadvisor
