Acrux Advances Female Testosterone Therapy to Phase III for HSDD Treatment
Key Insights
Acrux (search) has completed Phase I and II clinical trials for its Female Testosterone (search) product targeting Hypoactive Sexual Desire Disorder (search) (HSDD (search)) and received FDA feedback confirming a clear pathway to Phase III development.
The therapy addresses a significant unmet medical need, as HSDD (search) affects approximately 10% of peri and post-menopausal women, who represent 10% of the population.
The treatment utilizes Acrux (search)'s proprietary Patchless Patch™ delivery technology, offering women a precise, consistent, and discreet alternative to traditional testosterone gels or creams.
Australian pharmaceutical company Acrux (search) has announced its progression to Phase III clinical trials for a Female Testosterone (search) therapy designed to treat Hypoactive Sexual Desire Disorder (search) (HSDD (search)), marking a significant advancement in addressing an underserved women's health condition. The company has successfully completed Phase I and II clinical trials and received positive feedback from the US Food and Drug Administration (search) (FDA) confirming a clear regulatory pathway forward.
Addressing a Significant Unmet Medical Need
HSDD (search) affects approximately 10% of peri and post-menopausal women, who constitute 10% of the population. The condition, characterized by persistently low sexual desire that causes personal distress, represents the most prevalent sexual concern among women. In July, an FDA advisory panel emphasized the critical importance of developing treatments for women's health challenges, including HSDD.
Dr. Susan R Davis of Monash University, a leading global expert in HSDD (search), provided scientific context for the therapeutic approach: "Testosterone is not simply a male hormone but is also an important hormone in women. Low sexual desire is the most prevalent sexual concern amongst women. When sufficient to cause personal distress women are considered as having hypoactive sexual desire dysfunction or HSDD."
Clinical Evidence Supporting Testosterone Therapy
Dr. Davis highlighted the robust scientific foundation for testosterone treatment: "There is irrefutable evidence that testosterone therapy in doses that result in blood levels within the physiological range for premenopausal women improves sexual desire, arousal, orgasm, and sexual self-image and reduces personal distress in postmenopausal women with HSDD (search)."
The expert specifically endorsed Acrux (search)'s delivery approach, noting that "The Acrux' Testosterone MDTS has the advantages of acting as a 'patchless' patch with good pharmacokinetic evidence of absorption."
Innovative Delivery Technology
Acrux (search)'s Female Testosterone (search) product utilizes the company's proprietary Patchless Patch™ delivery technology, originally invented at Monash University over 25 years ago. This system offers women an alternative to traditional testosterone gels or creams, eliminating the need for hand application while providing precise, consistent dosing.
Felicia Colagrande, one of the original researchers who developed the technology and currently works at Acrux (search), expressed enthusiasm for the application: "I am so delighted that Acrux is working to get our Patchless Patch™ with Female Testosterone (search) available for HSSD. It means women will have a precise, consistent, discreet and easy to use option for their Menopause Hormone Therapy."
The same delivery technology has been successfully commercialized in Acrux (search)'s estrogen products Evamist® and Lenzetto (search)®, demonstrating the platform's proven track record in hormone replacement therapy.
Strategic Development and Partnership Plans
Acrux (search) is actively exploring co-development partnerships with organizations that have strong commercial experience in global women's health markets. This strategic approach aims to optimize Phase III clinical trial design and accelerate the path to market entry.
John Warmbrunn, Acrux (search) CEO and Managing Director, emphasized the significance of the development milestone: "Having Female Testosterone (search) in such and advanced stage of development allows Acrux to, again, demonstrate its excellence in innovation and to help change the lives of millions of women globally. Receiving the feedback from the FDA has cemented female testosterone as a core strategy for Acrux and means that we can have a real impact in women's health."
The company's previous success in commercializing hormone replacement therapy products positions it well for global market opportunities. Acrux (search) has established itself as a pioneer in patient-preferred solutions for testosterone treatment in males and is now extending this expertise to address women's health needs.
The FDA feedback confirming that Phase I and II clinical trial results provide a valid foundation for advancing to final development stages represents a crucial regulatory milestone, providing Acrux (search) with confidence in its pathway to US market registration.