Testosterone cream for postmenopausal women with HSDD submitted for UK licensing.

Perth, Australia and Guildford, England: Lawley Pharmaceuticals and its commercial partner in the UK, Andro Pharmaceuticals Ltd, are pleased to announce that a Marketing Authorisation Application (MAA) for AndroFeme^® Cream 10mg/ml (testosterone) for women was accepted for assessment by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on 16^th March 2023.

AndroFeme^® Cream 10mg/ml, a female specific testosterone formulation, is already licensed by Australian regulatory authorities since 2020 for the management of hypoactive sexual desire dysfunction (“HSDD”) in postmenopausal women.

HSDD is characterised by the loss or absence of sexual desire associated with personal distress which affects between 6-13% of women in Europe¹.

Lawley has appointed Andro Pharmaceuticals Ltd as its exclusive licensee and distributor in England, Scotland and Wales for AndroFeme^® Cream 10mg/ml.

“If granted marketing authorisation, and through partnering with Andro Pharmaceuticals Ltd, we will provide UK healthcare professionals and postmenopausal women access to a female specific formulation which will address the absence of a licensed testosterone treatment for HSDD” stated Michael Buckley, Lawley’s Medical Director.

About ANDROFEME^® Cream 10mg/ml (testosterone):

ANDROFEME^® Cream 10mg/ml (testosterone) is a cream containing 1% w/v (10mg/ml) testosterone B.P (17-β- Hydroxyandrost-4-en-3-one). This form of testosterone is identical to the testosterone produced by the ovaries of women and the testes of men.

About Testosterone and Hypoactive Sexual Desire Dysfunction (HSDD): Testosterone is the primary hormone that is vital for sexual motivation and desire. Although it is commonly considered as a male hormone, testosterone is also produced by women in much smaller amounts by the ovaries and adrenal glands.

A reduction in or an absence of sexual desire, thoughts, fantasies, responsiveness to erotic cues or stimulation is very common in menopause and perimenopause women over the age of 40 years. Medically any of the above symptoms that have persisted over several months or more with associated distress is classified as hypoactive sexual desire dysfunction (HSDD). Clinical studies have shown that testosterone therapy for postmenopausal women with HSDD and low levels of testosterone can be useful to increase desire and sexual satisfaction.²

 About Lawley Pharmaceuticals:

Lawley Pharmaceuticals is an Australian company that specialises in the manufacture of pharmaceutical grade body-identical testosterone creams for the treatment of various endocrine deficiencies and related medical conditions.

Please direct all enquiries to Michael Buckley, Medical Director, on: michaelb@lawleypharm.com.au

About Andro Pharmaceuticals:

Andro Pharmaceuticals is a new pharmaceutical company located in Guildford, UK focused on commercialising prescription medicines aimed at male and female endocrine healthcare.

Please direct all enquiries to: info@andropharm.co.uk

End of Release.

Document Code: UKNRMAR23-01

References: [1]. Nappi R et al. Management of hypoactive sexual desire disorder in women: current and emerging therapies. Int J Womens Health. 2010; 2: 167–175. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2971736/ 2. Islam, R. M. et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol 2019;7(10): 754-766.