Our patented delivery system used in STRIANT is the first-ever buccal system for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (primary or secondary hypogonadism).
In a 12-week, U.S. multicenter, open-label, single-arm, Phase 3 trial in 98 hypogonadal men, STRIANT returned 86.6% of patients to normal physiologic testosterone levels. STRIANT achieved these results without dose titration.
In another 7-day, European multicenter, open-label, parallel study, 96.6% of patients achieved normal testosterone levels, again without dose titration.
Also, STRIANT attains maximum serum testosterone concentrations within 10 to 12 hours after the first dose. This was shown in a phase I, prospective, randomized, double-blind, placebo-controlled cross-over study. Steady state was achieved after the second dose. This was shown in a phase 1, open-label pharmacokinetic study in 12 hypogonadal men.
STRIANT achieved testosterone concentration-time curves that were consistent when evaluated across a 12-week, multicenter, open-label, single-arm, Phase 3 study in 98 hypogonadal men (study 1), and a 7-day, multicenter, open-label, parallel study comparing STRIANT and an approved testosterone transdermal system in 29 hypogonadal men (study 2).
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