Ferring Pharmaceuticals Announces UK Launch of Testavan® (Testosterone 2% Gel) for the Treatment of Male Hypogonadism

WEST DRAYTON, England, September 24, 2018 /PRNewswire/ --

Ferring Pharmaceuticals today announced the launch of Testavan^® 20 mg/g transdermal gel for the treatment of adult male hypogonadism. Testavan^® is a new testosterone replacement therapy designed to restore testosterone levels to a normal range (300-1050 ng/dL) in adult males with hypogonadism.

Male hypogonadism (or low testosterone) is a condition characterised by testosterone deficiency and persistent clinical symptoms.^[1] Its incidence varies from 2-5% of males aged 40 years and above^[2] and sufferers can experience adverse physical and psychological effects, with a subsequent reduction in quality of life.^[3] Symptoms include decreased libido, erectile dysfunction, fatigue, loss of muscle mass, mood depression, osteoporosis and regression of secondary sexual characteristics.^[1],[2]

Testavan^® provides male hypogonadism sufferers with a new treatment option to help restore testosterone levels. It is a topical gel with a patented formulation, based on Ferring's Advanced Skin Technology (F.A.S.T.), that is designed to provide optimal absorption and bioavailability.^[4] The product is supplied in a metered dose dispenser that includes a hands-free cap-applicator for precise dispensing and application, which has been designed to help manage the risk of secondary transference.^[5]

In phase III trials, men treated with Testavan^® achieved normalised testosterone levels by month three, with improvements in quality of life and fatigue scores over three months, and early and sustained increase in erectile function score at one and three months. Assessment measures included testosterone responder rate, defined as the percentage of subjects achieving normalised levels of testosterone (300-1050 ng/dL); the Multidimensional Assessment of Fatigue (MAF); general well-being assessment (Short Form 12 Health Survey, SF-12); International Index of Erectile Function (IIEF).^[4],[6]

Overall, Testavan^® was well tolerated with the most common adverse events being application site reactions including rash, erythema, pruritus, dermatitis, dryness and skin irritation, occurring in 4% of subjects.^[5],[6]

"Low testosterone is a real concern for many men, affecting their quality of life and sexual function. It can also be associated with comorbidities including cardiovascular disease, diabetes, depression, poor bone health and rheumatoid arthritis," said Professor Mike Kirby, University of Hertfordshire and The Prostate Centre, London. "Testavan^® is an important new treatment option for men who are diagnosed with hypogonadism."

Restoring testosterone levels to within the normal range can result in improvements over time in muscle mass, mood, sexual desire, libido and sexual function including sexual performance and number of spontaneous erections.^[1],[2],[6]

Commenting on the launch, Ferring UK's General Manager, Sean Davis said, "We are delighted that Testavan^® is available to patients in the UK as it expands the treatment options available to men suffering with hypogonadism. Ferring Pharmaceuticals remain committed to providing high quality, innovative products for male urological and endocrine conditions, and the launch of Testavan^® highlights our dedication to improving the treatment of hypogonadism."

About male hypogonadism
Male hypogonadism is a condition characterised by low levels or absence of testosterone due to certain medical conditions, and signs and symptoms of testosterone deficiency. Male hypogonadism is reported to have an incidence of 2-5% in men aged 40-79 years and becomes more common with age.^[2] There is a substantial quality of life and clinical burden associated with hypogonadism in men, and can be associated with comorbidities such as diabetes, metabolic syndrome, cardiovascular diseases, and adverse bone health.^[2],[7]-[10]

About Ferring's Advanced Skin Technology (F.A.S.T)    
Ferring's Advanced Skin Technology (F.A.S.T), is a proprietary transdermal gel technology, which is designed to enable rapid absorption of testosterone through the skin.^[11]-[13]

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women's health, and in specialty areas within gastroenterology, urology and endocrinology. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at http://www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

References    

1. Khera M, et al. J Sex Med 2016;13(12): 1787-804
2. Dohle G. et al. Guidelines on Male Hypogonadism. EAU guidelines 2017. Available at: http://uroweb.org/guideline/male-hypogonadism/#note_4 Last accessed: August 2018
3. Dean JD, McMahon CG, Guay AT, et al. The International Society for Sexual Medicine's process of care for the assessment and management of testosterone deficiency in adult men. J Sex Med 2015;12:1660-1686.
4. Ferring Pharmaceuticals. Data on file 2018.
5. Testavan Summary of Product Characteristics. Ferring Pharmaceuticals.
6. Cunningham G et al. Efficacy and safety of a new topical testosterone replacement gel therapy for the treatment of male hypogonadism. Endocr Pract 2017;23(5):557-565.
7. Kalyani RR, Dobs AS. Androgen deficiency, diabetes, and the metabolic syndrome in men. Curr Opin Endocrinol Diabetes Obes2007;14(3):226-234.
8. García-Cruz E. et al. Metabolic syndrome in men with low testosterone levels: relationship with cardiovascular risk factors and comorbidities and with erectile dysfunction. J Sex Med 2013;10(10);2529-2538.
9. Rodriguez-Tolrà J. et al. Effects of testosterone treatment on bone mineral density in men with testosterone deficiency syndrome. Andrology 2013;1(4):570-575.
10. Zarotsky V. et al. Systematic literature review of the risk factors, comorbidities, and consequences of hypogonadism in men. Andrology 2014;2(6):819-834.
11. Alberti I. et al. Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery. Expert Opin Drug Deliv 2005;2:935-950.
12. Olsson H. et al. Pharmacokinetics and Bioavailability of a New Testosterone Gel Formulation in Comparison to Testogel in Healthy Men. Clin Pharmacol Drug Dev 2014;3(5):358-64.
13. Efros M., Carrara D., Neijber A. The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies. Andrologia 2016;48(6):637-645.

Date of preparation: Sep 2018
TSV/2049/2018/UK