Erectile
dysfunction (ED) is extremely common sexual disorder and said to affect as much
as 10 percent of the male population. Above the age of 40, nearly 52 % of men
are affected with this sexual disorder. Phosphodiesterase 5 (PDE5) inhibitors
are the first line therapy for ED.
Before July 2012, only two molecules –
sildenafil and tadalafil from this group were available for the treatment of ED
in India. Futher, sildenafil has a rapid onset of action but duration of action
is shorter while Tadalafil has a longer duration of action but is associated
with side effects of muscle pain and back pain. Thus, there was a need for
molecule having advantages of the existing agents with better tolerability
profile.
Udenafil is a newly developed, potent and selective PDE5 inhibitor
approved for treatment of ED. It is a patented molecule developed by M/s Dong-A
Pharmaceuticals, Korea. It is the fourth among the
PDE5 inhibitors class at the time of approval (first approved in Korea – Dec.
2005). Udenafil has come into Indian
Market since July 2012. The unique features of this novel molecule include:
(1)
Unique clinical properties of relatively rapid onset and longer
duration of action - optimal pharmacokinetic
profile - Tmax of 1-1.5 hours and a Half-life of 11-13 hours.
(2)
Efficacious in the treatment of ED -
broad-spectrum aetiology and severity
(a)
There was significant
improvement in IIEF, SEP and GAQ parameters in ED patients in the udenafil
group in various clinical trials
(b)
Efficacious in ED with co
morbidities, i.e. Specific studies in ED patients with hypertension
(HT)/diabetes mellitus (DM) showed significant improvement in erectile function
in ED patients with HT/DM.
(3)
Well tolerated –
(a)
Udenafil has not been reported for adverse effects on myalgia,
back pain and testicular toxicity (Unlike
tadalafil). Udenafil does not inhibit PDE11 (>3000 fold selectivity for
PDE5 compared to PDE11) unlike tadalafil (5 fold selectivity for PDE5 compared
to PDE11).
(b)
Incidence of dyspepsia appears to be less
(c) In
clinical trials it has been observed that udenafil rarely causes vision related
adverse events (blurred vision, eye pain and chromatic vision) with incidence
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(4) Less lifestyle interactions
(a)
Udenafil can be taken
without regard to meals (food)
(b)
Udenafil does not
potentiate the hypotensive effect of alcohol in healthy volunteers
Besides
Korea, udenafil was launched subsequently in Russia, Malaysia and Philippines.
Udenafil is also approved and marketed in Ukraine, Uzbekistan, Kyrgyzstan and Turkey. The regulatory activities are
also ongoing for approval of udenafil in USA.
A randomized, double-blind, placebo
controlled, multi-centric, phase III clinical trial was conducted in India
which clearly demonstrated that udenafil 100 mg tablets taken as on-demand, 30
minutes to 1 hour before anticipated sexual intercourse was significantly more
effective as compared to matching placebo tablets in Indian patients suffering
from ED. On the tolerability front, udenafil 100 mg tablets was very well
tolerated. Udenafil
thus appeared to be a suitable therapeutic modality for the treatment of ED in
Indian patients.
A recently published review (Therapeutic Advances in Urology published online 14 December 2012) mentions
ñ Udenafil’s efficacy and
tolerability have been evaluated in several studies, and recent and continuing studies have demonstrated udenafil’s
promise in both dosing regimens. (on-demand and once-daily)
ñ If some patients wish to receive a long-acting PDE5 inhibitor, but
experience side effects with tadalafil, udenafil might be a more appropriate
option
ñ The literature reviewed here indicates that udenafil seems to be
safe and well tolerated in general ED patients in Korea.
ñ Udenafil seems to be an
ideal PDE5 inhibitor, with both short onset time and long duration.
Udenafil may be a reliable treatment option in patients who have
relatively spontaneous and unscheduled sexual intercourse.
Indian response to
Udenafil is encouraging and
leading urologists/andrologists/sexologists across India have started
prescribing it. Udenafil is a welcome addition to current management of ED as it assists
clinicians in tailoring treatment regimens to the unique needs of each patient
with ED.
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