Celebrating 10 Years of Addyi®: A Milestone in Women's Health Innovation

Introduction

As we celebrate the 10th anniversary of Addyi® (flibanserin 100mg), we reflect on its transformative impact in the realm of women's sexual health. Approved by the U.S. Food and Drug Administration (FDA) in 2015, Addyi® is not just a medication; it symbolizes a groundbreaking shift in how women's sexual health issues are perceived and treated. Sprout Pharmaceuticals has championed this cause, facing challenges and breaking down barriers to promote a better understanding of the complexities surrounding women's sexual wellness.

The Journey of Addyi®

Ten years ago, Sprout Pharmaceuticals, led by CEO Cindy Eckert, made history by securing approval for Addyi®, the first FDA-approved oral medication specifically designed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. The journey to this landmark approval involved rigorous clinical trials, showcasing the commitment to evidence-based medicine and the necessity for a dedicated pharmaceutical approach to women’s sexual health. The initiative involved data from over 13,000 patients—three times more than typically required for male-focused studies.

Eckert's vision went beyond merely launching a new drug; it aimed to ignite a global dialogue about women's sexual health that had been muted for decades. This pursuit relieved the stigmas associated with women's health issues and brought them to the forefront of clinical and public discourse.

Tackling Unmet Needs

Hypoactive Sexual Desire Disorder is recognized as the most common form of female sexual dysfunction, yet treatment options historically lagged behind those available for men. The impact is profound, with at least 40% of women reporting low sexual desire at some point in their lives, coupled with limited avenues for treatment. Addyi® offers a unique solution by acting on brain neurotransmitters rather than focusing solely on blood flow, which differentiates it from medications used by men.

Since its launch, over 30,000 healthcare providers in the United States have prescribed Addyi®, demonstrating a significant shift in treating and discussing female sexual health. Medical professionals like Dr. Alyse Kelly-Jones and Dr. Jila Senemar have noted the medication's role in fostering open conversations with patients, empowering women to reclaim their sexual well-being.

Building a Legacy

A decade into its journey, Addyi® continues to evolve, with its price becoming more accessible, starting as low as $20 per month with insurance. Notably, the drug no longer carries a Risk Evaluation and Mitigation Strategy (REMS) requirement or alcohol contraindication, further enhancing women's access to effective treatment options.

In 2025, the FDA granted a Priority Review for Sprout's supplemental application aimed at expanding Addyi®'s indications to include women who have undergone menopause, indicating continued advancement in women's healthcare. This potential approval could provide access to millions of women wanting to address their sexual health at every stage of life, magnifying the drug's societal impact.

Looking Forward

Cindy Eckert emphasized that the mission to drive innovation and expand access remains vital. Reflecting on the past decade, she articulated the goal to redefine care, extending opportunities for informed decision-making and choice tailored to women's health. As Addyi® continues to break stigma and normalize discussions of sexual health, its legacy will undoubtedly pave the way for future advancements in women's healthcare.

Conclusion

The last ten years have marked a significant chapter in the landscape of women’s health, not only for Sprout Pharmaceuticals but for healthcare providers and women alike. The story of Addyi® is one of persistence, advocacy, and revolutionary change in addressing women’s sexual health issues. As we look to the future, the focus must remain on innovation and equal access to health care that truly caters to the unique needs of women everywhere.