Arletta Pharma Solutions Emerges as New Name in Female Sexual Health, Advances Lybrido™ Clinical Development
Amsterdam, the Netherlands – Freya Pharma Solutions, a pharmaceutical company dedicated to therapies for Female Sexual Disorders (FSD), announced its rebranding to Arletta Pharma Solutions, effective December 1, 2025. The new identity, symbolizing transformation through the “Arletta” butterfly, coincides with the company’s progression toward crucial clinical milestones for its lead compound, Lybrido™. This strategic rebranding underscores a renewed focus on addressing the significant unmet medical needs of women worldwide affected by FSD.
The Symbolism of the Arletta Butterfly in Women’s Healthcare
“Like a caterpillar emerging as a butterfly, this name change marks the beginning of our company’s final phase,” stated Nicole Hijnen, CEO of Arletta Pharma Solutions. The butterfly, a universal symbol of transformation, change, beauty, and freedom, resonates deeply within women’s health to represent the various biological and life changes women experience. From puberty through reproductive years, perimenopause, and postmenopause, women undergo significant physiological and hormonal shifts that often necessitate specialized medical care and understanding. The company’s focus on developing innovative treatments for Female Sexual Interest/Arousal Disorder (FSIAD) acknowledges these unique transitions and the need for targeted therapeutic solutions that respect the complexity of female sexual health.
Moreover, global health organizations continue to prioritize women’s health, recognizing the importance of addressing conditions that impact quality of life. The World Health Organization (WHO), for instance, recently highlighted priority endemic pathogens for which new vaccines are urgently needed, emphasizing a broad commitment to global health that includes addressing a spectrum of conditions affecting various populations, including women [who.int](https://www.who.int/news/item/05-11-2024-who-study-lists-top-endemic-pathogens-for-which-new-vaccines-are-urgently-needed).
Advancing Clinical Programs for FSIAD Treatment
Arletta Pharma Solutions is currently advancing its Clitoral Doppler Duplex Ultrasonography (CDU) Phase II study at the Chaim Sheba Medical Center. This study is evaluating two testosterone-sildenafil dose combinations in 16 premenopausal women diagnosed with acquired generalized FSIAD. The research, led by Prof. Cobi Reisman and Dr. Anna Padoa, utilizes clitoral doppler duplex ultrasound imaging to quantify clitoral blood flow parameters, with preliminary data anticipated in the near term. This objective measurement is crucial for understanding the physiological impact of Lybrido™. Furthermore, the company is preparing for the ALETTA pivotal study, which is expected to be conducted across 20 European research sites in five countries. Enrollment is poised to begin following the completion of financing arrangements, a critical step toward regulatory approval in Europe.
The development of therapies for conditions like FSIAD is vital, as research into various long-term health conditions, such as Long COVID, also presents challenges in diagnosis and treatment due to a lack of consensus on definitions and underlying pathological mechanisms. This underscores the broader medical community’s need for rigorous clinical research to establish clear diagnostic criteria and effective interventions across different health spheres [thelancet.com](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01136-X/fulltext).
Fifteen Years of Research Fueling Lybrido™ Development
Arletta Pharma Solutions’ flagship product is Lybrido™, an innovative on-demand dual-action therapy designed to treat FSIAD and Hypoactive Sexual Desire Disorder (HSDD). The development of Lybrido™ builds upon 15 years of dedicated research in the field of female sexual disorders. The therapy features a unique dual-route, dual-release tablet. It comprises a testosterone coating for sublingual administration and an inner core of sildenafil, a PDE-5 inhibitor. This advanced design ensures a delayed-immediate-release matrix that synchronizes the peak plasma concentration of sildenafil with the testosterone-induced window of increased sexual motivation. This mechanism is intended to enhance genital arousal by increasing responsivity to sexual stimuli, with effects lasting typically three to six hours post-intake. To date, Lybrido™ has undergone investigation in 20 Phase I and Phase IIa trials, as well as large-scale Phase IIb trials across 17 research sites in the United States.
The pharmaceutical industry’s focus on targeted therapies, like Lybrido™, aligns with broader efforts to improve health outcomes efficiently. Experts often assess the value for money of healthcare interventions by analyzing technical cost-effectiveness and the political feasibility of expanding coverage for specific drugs, vaccines, and diagnostics [globalhealth2050.org](https://globalhealth2050.org/files/2024/10/Lancet2050.pdf).
Understanding Female Sexual Disorders
Low sexual desire is recognized as the most prevalent female sexual disorder, often leading to significant clinical distress, dissatisfaction in intimate relationships, and a profound negative impact on emotional well-being. FSIAD, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), encompasses persistent reductions in sexual interest and/or arousal lasting at least six months and causing clinically significant distress. This diagnosis combines concepts previously categorized as Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, which are listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under codes HA00/HA01.0. The rebrand by Arletta Pharma Solutions and the continued clinical development of Lybrido™ represent a significant step in addressing this critical area of women’s health.
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