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While many different forms of testosterone are available in the United States for the treatment of androgen deficiency, one fundamental type is lacking ? an oral testosterone medication. This has been a major technical hurdle, as testosterone is too easily broken down during the digestive process to be made into a standard capsule or tablet. A new company called Clarus Therapeutics thinks it may have an answer. This firm has been funding clinical studies on a new formulation of testosterone undecanoate (TU) called a self-emulsifying drug delivery system (SEDDS). A study was published on the formulation just this week in the Journal of Andrology, and presented favorable results (1). Is it possible that an oral testosterone capsule is finally on its way to the U.S.?
It would be incorrect to say this is a first. Oral testosterone medications already exist in other countries, and have for decades. In particular, many other places including Canada, Mexico, and Western Europe have access to Andriol (Schering-Plough), which is an oral capsule that contains TU in oil. This formulation is designed to allow some of the hormone to be absorbed through the lymphatic system, thereby avoiding ?first pass? metabolism by the liver. While this medication is clinically viable, it also presents large differences in individual pharmacokinetics. It works well for some, and very poorly for others. This lack of consistency has made Andriol a poor candidate for FDA approval. Clarus apparently believes it may have solved this inconsistency problem with a new delivery system.
In this particular clinic study, subjects were given either 200 mg or 300 mg doses of testosterone undecanoate SEDDS once or twice daily. Subjects were also tested when the medication was taken in the fasted state, and with meals. The duration of use was in three stages, an acute (single dose) study, a 7-day period, and a 28-day period of intake. The study found that 200 mg of TU SEDDS given twice daily with meals was sufficient to maintain physiological concentrations of testosterone in most subjects. As with regular Andriol, taking the medication in a fasted state resulted in significantly lower serum hormone levels. The 300 mg dose twice daily was also effective, but also resulted in supraphysiological hormone levels in some subjects. More research on this new form of oral testosterone is expected.
References:
(1) J Androl. 2011 Apr 7. [Epub] Re-Examination of Pharmacokinetics of Oral Testosterone Undecanoate in Hypogonadal Men with a New Self-Emulsifying Formulation. Yin AY, Htun M et al.
It would be incorrect to say this is a first. Oral testosterone medications already exist in other countries, and have for decades. In particular, many other places including Canada, Mexico, and Western Europe have access to Andriol (Schering-Plough), which is an oral capsule that contains TU in oil. This formulation is designed to allow some of the hormone to be absorbed through the lymphatic system, thereby avoiding ?first pass? metabolism by the liver. While this medication is clinically viable, it also presents large differences in individual pharmacokinetics. It works well for some, and very poorly for others. This lack of consistency has made Andriol a poor candidate for FDA approval. Clarus apparently believes it may have solved this inconsistency problem with a new delivery system.
In this particular clinic study, subjects were given either 200 mg or 300 mg doses of testosterone undecanoate SEDDS once or twice daily. Subjects were also tested when the medication was taken in the fasted state, and with meals. The duration of use was in three stages, an acute (single dose) study, a 7-day period, and a 28-day period of intake. The study found that 200 mg of TU SEDDS given twice daily with meals was sufficient to maintain physiological concentrations of testosterone in most subjects. As with regular Andriol, taking the medication in a fasted state resulted in significantly lower serum hormone levels. The 300 mg dose twice daily was also effective, but also resulted in supraphysiological hormone levels in some subjects. More research on this new form of oral testosterone is expected.
References:
(1) J Androl. 2011 Apr 7. [Epub] Re-Examination of Pharmacokinetics of Oral Testosterone Undecanoate in Hypogonadal Men with a New Self-Emulsifying Formulation. Yin AY, Htun M et al.