It
is estimated that Erectile Dysfunction
(ED) affects more than half of all men
over 40 years of age, or 140 million men
worldwide. However, only one in 20
receives medical treatment,
demonstrating the clear need for
additional therapies in this area.
Sildenafil (Viagra®), the
only oral medication that is currently
commercially available to treat ED, is
not always successful and requires
approximately one hour to exert its
effect. Additionally, sildenafil has
been associated with a variety of side
effects and drug interactions.
Two other
medications, tadalafil and vardenafil,
are currently under research and
development. Drug-related adverse
effects, with headache in up to 23% of
patients (placebo, 17%), indigestion in
up to 11% (placebo, 7%), and back pain
in up to 4.7% (placebo, 0%) were mostly
mild to moderate. Neither serious
drug-related cardiovascular problems nor
color vision disturbances were
encountered. These drugs remain active
in the body for a longer period of time
than sildenafil.
Apomorphine
is another medication that works on
areas in the brain known to be involved
in erectile function. More than 5,000
men with ED participated in clinical
trials assessing the safety and efficacy
of apomorphine, which is taken
sublingually (under the tongue),
dissolves rapidly, is effective in
approximately 60% of patients, and
results in an erection in about 20
minutes. However, in the U.S., its New
Drug Application was withdrawn amid
concerns of patients who had fainted
after taking the medication, decreases
in blood pressure when apomorphine was
taken concurrently with nitrates, and
potential interactions with alcohol.
Nausea was reported in 16% of patients
taking low doses (2 mg). Apomorphine is
commercially available for the treatment
of ED in Europe (Apo®, Uprima®).
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