New testosterone 2% gel using Ferring Advanced Skin Technology (FAST), for the treatment of testosterone deficiency in men, with a novel applicator

ABSTRACT

Introduction

Testosterone deficiency (TD) is an increasing problem that can affect a man’s physical and psychological health, and quality of life. Testosterone replacement therapy (TRT), combined with weight reduction, lifestyle advice, and the treatment of co-morbidities, is the treatment of choice in men who are not concerned about fertility. However, there remains an unmet need in this therapeutic area, relating to factors such as inconvenient or painful administration, fluctuations in testosterone levels, supra-physiologic testosterone levels, poor tolerability, and secondary safety issues, which may be associated with the current TRT options. Advances in transdermal delivery systems have resulted in the development of a new 2% transdermal testosterone gel, that may offer some additional features over the other currently available TRTs.

Areas covered

We performed a comprehensive review of the published and gray literature to identify randomized studies and non-randomized studies (NRS) involving adult men receiving treatment for low testosterone levels.

Expert opinion

Topical gels are often the most convenient first-line treatment for testosterone deficiency, but options are important as patient preference is more important than virtually any other clinical area of medicine. The chosen therapy must be convenient to use and reach reliable therapeutic levels to effectively and consistently relieve symptoms. Testavan, a new 2% testosterone gel, goes some way to achieving these goals.

KEYWORDS:

• Testosterone
• testosterone deficiency
• testosterone replacement therapy
• transdermal delivery systems
• testosterone gel
• testavan

Article highlights

• TD and ED are now recognized as independent risk factors for CVD.

• TD is not a simple consequence of male aging but is associated with important co-morbidities. Eighty percent of men maintain adequate testosterone levels throughout life.

• Screening for TD is now recommended by several International expert guidelines in all men with type 2 diabetes, metabolic syndrome, ED, and type 2 diabetes.

• TRT for men with low testosterone levels, who fail with generic PDE5 inhibitors, may be more acceptable and cost-effective than proceeding to second-line ED therapies.

• Patients with TD present with bothersome clinical symptoms and expect these to be treated.

• Multiple therapy options are required to address patient expectations.

• There are several unmet needs with currently available therapies.

• New therapies and combination strategies are required to meet patient unmet needs.

• Testavan is a new 2% transdermal testosterone gel.

• In phase III trials, Testavan treatment restored serum testosterone levels in men with TD and was associated with commensurate improvements in fatigue, sexual function, and quality of life.^25,26

• Testavan was well tolerated in phase II and III trials, with the most common adverse events being application site reactions, affecting 4% of subjects.²⁸

• With greater and more rapid absorption than Testogel, and testosterone peaks clearly above the steady-state level, Testavan may provide a treatment effect that more closely mimics that of the natural diurnal variation in testosterone.¹⁹

• Testavan’s optimal absorption and bioavailability, smaller treatment volumes and applicator application may reduce the risk of secondary transference of testosterone¹⁵ and therefore improve compliance in men who are concerned about this.

Declaration of interest

M Kirby has received funding for research, conference attendance, lecturing and advice from Astellas, Pfizer, Takeda, Bayer, Besins, MSD, Boehringer Ingelheim, Lilly, GlaxoSmithKline, AstraZeneca, Daiichi-Sankyo, Ferring and Menarini. M Kirby is Editor of Trends in Urology & Men’s Health and on the Prostate cancer Risk Management Programme NHS advisory board, and a member of the Prostate Cancer advisory Group. M Kirby is also a member of the National Prostate Cancer Audit Group. A Kalhan has received funding for research, conferences and guest lectures from AstraZeneca, Novo Nordisk, Lilly, Boehringer Ingelheim, Takeda and MSD. G Hackett has been a speaker for Bayer and Besins. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Information resources

Bhasin S, Brito JP, Cunningham GR et al.l Testosterone therapy in men with Hypogonadism, An Endocrine Society Guideline. J Endocrinol Metabolism 2018:103(5):1-30.

Hackett G, Kirby M, Edwards D et al. The BSSM Guidelines on Adult Testosterone Deficiency, with statements for UK practice. J Sex Med 2017;14: 1504-23.

Mulhall JP, Trost LW, Brannigan RE et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol 2018;200:423-32.AUA.

Additional information

Funding

This paper was not funded.