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Testosterone buccal system (Striant): comparison with other routes of administration in hypogonadal males

Testosterone buccal system (Striant): comparison with other routes of administration in hypogonadal males

It has been hypothesised that buccal administration of testosterone (T), by preventing first-pass catabolism by the liver, may be a viable alternative to gels, patches and injectables. This abstract compares the pharmacokinetic/clinical pharmacological profiles of several routes of administration. Two studies were undertaken. In both Striant (30mg testosterone buccal system) was administered twice daily (at circa 08.00 and 22.00). In one 14-day, open label study in 26 hypogonadal males at 4 sites a comparison was made with Androgel (5g containing 50mg T ), daily. In the second in 67 patients at 5 sites the comparison was with Androderm (5mg) and /or Andropatch (5mg) for 7 days.

In the first, starting from similar baselines, Striant and Androgel produced equivalent increases in T levels (Cavg (0-24) 4.8 and 4.4 ng/ml, respectively). The percentage of patients achieving Cavg (0-24) within the normal range were 92% and 83% for the buccal and gel formulations respectively, with 84% (buccal) and 75% (gel) remaining within the normal physiological range over any 24hr period. In contrast, differences were observed between Striant and patch delivery. In particular, the T Cavg (0-24) achieved for Striant was much higher (5.4+/-1.7ng/ml) than that for patches (3.5+/-1.6ng/ml) a difference which was reflected in the percentage of patients achieving physiological levels (97% and 56% respectively for buccal and patch delivery systems).
Based on pharmacokinetic and/or clinical pharmacology parameters, Striant has an equivalent profile to T gel and a profile superior to that obtained using patch technology.

Speakers: Michael Wyllie
Conference: WAS Glasgow 2011
Areas of Interest / Categories: Androgen Therapy, WAS 2011

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