Testosterone

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Articles

Lactation Safety Information

For breast cancer

For breast cancer
Low levels anticipated in milk due to the drug's properties
May interfere with lactation
Very limited published evidence of safety

New Medicines

Testavan · Hypogonadism in men

Information

Testavan
New formulation
Ferring
Ferring

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
September 2018
Sep 18 · Testavan is now available in the UK. It costs £26.64 for 1 x pump (with hands-free applicator); each pump contains 85.5 g transdermal gel and dispenses 56 metered doses [5].
Mar 18 · Ferring announce positive outcome of European Decentralised Procedure for Testavan® for men with hypogonadism [4].
Aug 17 · Ferring pipeline lists Testavan as pre-registration; assume both EU & US [2].
Jan 16 · Has been filed in the US [1].

Category

Topical testosterone gel
The incidence of low testosterone and symptoms of hypogonadism in men aged 40-79 varies form 2.1-5.7%. Hypogonadism is more prevalent in older men, in men with obesity, those with co-morbidities, and in men with a poor health status [1].
Hypogonadism in men
Topical

Trial or other data

Jun 15 · Ferring completed an open-label, single-arm PIII trial that assessed the efficacy and safety of topical testosterone gel, administered with an applicator, in men with hypogonadism (testosterone <300 ng/dL) (NCT02149264). The primary endpoint is the percentage of patients who achieve an average concentration of serum total testosterone between 300 and 1050 ng/dL at 90 days. The trial enrolled 160 patients in the US [1].
Aug 12 · Ferring initiates an open-label, single-arm PIII trial in the US and Canada to determine the efficacy, pharmacokinetics and safety of topical testosterone gel (via an applicator) in men with hypogonadism (testosterone <300 ng/dL) (NCT01665599). The primary outcome was the proportion of patients achieving average serum testosterone levels between 300 and 1050 ng/dL at 90 days [1].

Xyosted · Hypogonadism

Information

Xyosted
New formulation
Antares Pharma
Antares Pharma

Development and Regulatory status

None
None
Approved (Licensed)
Nov 19 · No further development reported. Company has no UK presence so assume no plans for UK launch.
Oct 18 · Approved in the US for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, e.g. primary hypogonadism, hypogonadotropic hypogonadism. The company plans to launch with a monthly list price of $400-500 which is less than AndroGel´s list price of $625 [1].

Category

Testosterone replacement therapy administered subcutaneously [1]
The crude incidence rate of symptomatic androgen deficiency was 12.3% per 1000 person-years and increased with age: 5.9%, 11.2%, and 23.3% per 1000 person-years in men who were in their 40s, 50s, and 60s, respectively, at baseline.
Hypogonadism
Subcutaneous injection