Wonder why I didn't know about this...
Early studies confirmed the feasibility of delivering testosterone
replacement to patients across the buccal mucosa (Dobs
1998; Baisley et al., 2002). Buccal delivery avoids first-pass
metabolism because venous drainage from the mouth is into the
superior vena cava, allowing the use of unmodified testosterone.
Following these initial studies using short-acting tablets, recently
a sustained-release mucoadhesive buccal tablets, (Striante SR),
which contains 30 mg of unmodified testosterone has been
licensed in the USA and in Europe. This twice-daily buccal
tablet is placed in the small natural depression in the mouth
above an incisor tooth on either side of the mouth, providing a
discreet form of therapy.
Testosterone replacement therapy update
Page 7 of 11
Treatment with this tablet restores serum testosterone concentrations
to within the normal range within 4 h of application, and
steady-state concentrations are achieved within 24 h (Ross et al.,
2004). Mean testosterone levels are maintained within the physiological
range (Dobs et al., 2004; Korbonits et al., 2004; Wang
, 2004) similar to that seen in normal young men. Serum
DHT levels increase parallel to serum testosterone into the normal
range (Dobs et al., 2004; Wang et al., 2004) and not as high
as with trans-scrotal patches.
In Phase III clinical trials, 87–97% of patients achieved 24 h
time-averaged serum concentrations of testosterone within the
normal range (Dobs et al., 2004; Korbonits et al., 2004; Wang
, 2004). Compared with patients receiving Andropatchw
(50 mg at night), patients treated with Striant
e SR were more
likely to achieve levels of testosterone within the physiological
range (Korbonits et al., 2004). A small 14-day study suggested
that the buccal system produced mean steady-state testosterone
levels comparable to those with a testosterone gel (Dobs et al.,
2004). In these trials, the buccal testosterone tablet was generally
well tolerated, with the most common adverse event being
application site irritation, although these events were infrequent,
usually mild or moderate, and rarely led to treatment discontinuation
(Dobs et al., 2004; Korbonits et al., 2004; Wang et al.,
2004). This new preparation may be chosen by patients preferring
a self-applicable substitution that can be orally administered.