Ferring Announces Positive Outcome of European Decentralised Procedure (DCP) for Testavan®, a Treatment for Men with Hypogonadism
Ferring Pharmaceuticals today announced the positive outcome of the European Decentralised Procedure (DCP) for Testavan® (transdermal testosterone gel 2%), a testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. The Netherlands acted as Reference Member State (RMS) on behalf of all 31 European Economic Areas (EEA) countries.1
“Men suffering from hypogonadism symptoms, including erectile dysfunction and fatigue, often remain untreated due to barriers that delay diagnosis and lack of treatment options ,” said Per Falk, Executive Vice President and Chief Science Officer, Ferring Pharmaceuticals. “Ferring is committed to delivering innovative healthcare solutions to treat a number of male urologic conditions. With the positive outcome of the DCP, hypogonadal patients in many European countries will soon have access to a convenient treatment to normalise testosterone and relieve symptoms. ”
Testavan’s fast-drying gel formulation is based on Ferring’s Advanced Skin Technology (F.A.S.T.), a proprietary transdermal gel technology, which enhances bioavailability of testosterone through the skin. Testavan’s low dose and volume, in addition to its unique hands-free applicator, were designed to ensure patient convenience. The hands-free applicator may lower the risk of transference of testosterone skin residue from the patient to others.8- 10
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).
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 2-6% in men aged 40-79 years and becomes more common with age.3 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 bonehealth.3,11-14
Testavan, the new 2% testosterone gel, uses a proprietary hydroalcoholic and highly viscous topical formulation. The product is homogeneous, transparent and nonstaining, and comes in a metered dose dispenser that includes a hands-free cap applicator for precise dispensing and application. The starting dose is 23 mg testosterone, delivered by one pump actuation, contained in 1.15 g of gel, and the highest dose is 3.45 g of gel containing 69 mg testosterone (delivered by 3 pump actuations).1
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 and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. 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.
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Ferring Pharmaceuticals. Data on file 2018.
2 Nieschlag E, Behre HM (eds). Andrology: male reproductive health and dysfunction. 3rd edn. Heidelberg: Springer, 2010.
3 Dohle G. et al . Guidelines on Male Hypogonadism. EAU guidelines 2017. Available at: http://uroweb.org/guideline/male-hypogonadism/#note_4 Last accessed: March 2018
4 Belkoff L. et al . Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open label studies. Andrologia 2018 Feb;50(1). doi: 10.1111/and.12801. Epub 2017 Mar 10.
5 Arver S. et al . A new 2% testosterone gel formulation: A comparison with currently available topical preparations. In Press. Andrology 2018.
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 Testavan Summary of Product Characteristics. Ferring Pharmaceuticals.
8 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.
9 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.
10 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.
11 Kalyani RR, Dobs AS. Androgen deficiency, diabetes, and the metabolic syndrome in men. Curr Opin Endocrinol Diabetes Obes 2007;14(3):226-234.
12 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.
13 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.
14 Zarotsky V. et al . Systematic literature review of the risk factors, comorbidities, and consequences of hypogonadism in men. Andrology 2014;2(6):819-834.
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