With the onset of menopause, many women experience a decline in libido known as hypoactive sexual desire disorder (HSDD) that can lead to emotional and psychological distress, and a reduced quality of life. Many existing therapies for the myriad physiological changes associated with menopause target the rapid decline in estrogens seen during this transitional life stage.
Testosterone and HSDD
The role of testosterone in postmenopausal symptoms has long been recognized, especially for sexual functioning. A 2019 global position statement endorsed by numerous endocrinology and women’s health organizations recommended the use of testosterone for the treatment of HSDD in postmenopausal women who have not responded to other hormone-replacement therapies and do not have comorbidities such as depression1.
In the UK, the National Institute for Health and Care Excellence (NICE) has also recommended testosterone for HSDD in postmenopausal women2. Current guidelines point to transdermal delivery as providing the best route of administration for restoring testosterone to physiological levels seen in women prior to menopause3.
Despite these endorsements, no testosterone product has yet been approved for women experiencing HSDD. However, the combination of a solid evidence base supporting its use in HSDD and growing public awareness of its benefits means that many postmenopausal women seek out testosterone treatment.
When physician or general practitioners (GP’s) prescribe testosterone, typically in the form of a cream or gel, they do so off-label. As a result, women often receive treatments designed for and tested on men, whose baseline levels of physiological testosterone levels differ significantly from those of women. In other cases, doctors may be reluctant to prescribe testosterone at all in the absence of a product approved specifically for women.
Addressing the gap
Medherant—a clinical-stage company focused on transdermal drug delivery for the treatment of women’s health, pain and disorders of the central nervous system—is charting a course to remedy this unsatisfactory situation. The company’s lead product, the testosterone TEPI patch for HSDD in postmenopausal women, is currently in a phase 1 trial.
Advantages of the patches: Superior wearability; no irritation or sensitization; improved dose control; extended release; excellent adhesion
Patches offer many advantages over creams or gels. Patches enable more controlled dosing, and are less messy than gels or creams, which can leave active pharmaceutical ingredients (APIs) on the hands that can be passed on to others by touch. But not all patches are created equal. The TEPI patch has been developed with a unique, pressure-sensitive adhesive that serves both to deliver APIs such as testosterone and to bind the patch to the skin.
Patches utilizing Medherant’s proprietary adhesive, created by company founder and CSO David Haddleton and his team, have been well tolerated in phase 1 trials, and have a number of advantages over other adhesive formulations. The novel adhesive has a high drug- and excipient-loading capacity—up to 50% by weight—and can be developed as extended-release formulations, allowing dosing for up to seven days.
These features support transdermal delivery of lower-potency drugs, in addition to reducing the size and thickness of the patches required compared with available commercial products.
TEPI patches also achieve superior adhesion, optimizing drug delivery as they stay in contact with the skin. They are water-resistant and shower-proof, and remain in place for up to a week.
Once used, TEPI patches are easy and painless to remove, and do not leave a dark residue unlike many other products. TEPI patches are simple, convenient, and easy to use, resulting in better patient compliance compared to creams and gels.
Partnering to advance transdermal patch products
The adhesive in TEPI patches can also be modified to contain permeation enhancers and other excipients, which may improve the pharmacokinetics and safety profile of drugs. TEPI patches can deliver a wide range of drugs, providing opportunities for the delivery of novel therapeutics as well as product line extensions.
The advantages and possibilities of Medherant’s TEPI patch have been recognized by other drug developers, and the company has entered into a product-development collaboration with healthcare giant Bayer.