AndroFeme 1 licensed for hypoactive sexual desire dysfunction in postmenopausal women

Lawley Pharmaceuticals  has obtained approval for registration of AndroFeme^® 1 in the Australian Register of Therapeutic Goods (ARTG) for the treatment of postmenopausal women experiencing low sexual desire with associated personal distress, also known as hypoactive sexual desire dysfunction or HSDD. An estimated 1 in 3 Australian women aged 40 to 64 years experience HSDD. Australian postmenopausal women will now have access to a medically prescribed, clinically effective testosterone formulation which meets the requisite quality and safety standards for registration, for the management of HSDD.

For Perth-based Lawley Pharmaceuticals founder and CEO Michael Buckley, it is a decision that has been two decades in the making. “This is the first approval that addresses the need for a female-specific, regulated testosterone formulation for women.”  Mr Buckley said.  “It’s a ground-breaking decision for women across Australia, and hopefully in the near future, for women around the world.”

AndroFeme^® 1 is a cream containing the hormone testosterone and is applied daily to the skin. The testosterone in AndroFeme^® 1 is identical to the testosterone that the ovaries and adrenal glands would produce. Once applied the testosterone passes into the blood stream where it increases serum testosterone concentrations into the approximate physiological levels of premenopausal women.

Australian specialists and researchers have for decades pioneered ground-breaking research into female sexual dysfunction and testosterone use in women. This collective of work culminated in September 2019 with the release of the Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) which was endorsed by almost 20 of the world’s leading medical societies and associations.

The first author of the Global Position Statement is Australian Professor Susan Davis, endocrinologist and Director of Melbourne’s Monash Women’s Health Research Program.

“ There is irrefutable evidence that testosterone therapy, at a dose that results in premenopausal blood testosterone levels in postmenopausal women, can be highly effective for the treatment of postmenopausal women with low sexual desire and associated personal distress, or HSDD,” Professor Davis said.

“This is a global milestone in terms of gender equity, with the TGA being the first regulatory agency in the world to approve a treatment for sexual dysfunction for postmenopausal women”.

Since 1999, due to unique legislative differences between the State of Western Australia and the Commonwealth, AndroFeme^® 1 has only been available for dispensing from WA-based pharmacies.

“This decision is a major step toward addressing the gender disparity in the treatment of sexual dysfunction that has existed for managing a very personal problem that is a source of significant distress for many women,” Mr Buckley said.

“The registration of AndroFeme^® in the ARTG opens the door to international markets and Lawley Pharmaceuticals will actively be seeking out-licensing opportunities.”

AndroFeme^® 1 is expected to be available in pharmacies nationally from April 2021.