8/8/2019 LEVITRA 10mg Orodispersible Tablet for the Treatment of
Erectile Dysfunction Approved in Europe
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LEVITRA 10mg Orodispersible Tablet For The Treatment Of
ErectileDysfunction Approved In Europe
Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Regulatory Affairs / Drug Approvals; Pharma
Industry / Biotech Industry
Article Date: 07 Sep 2010 - 0:00 PDT
The European Commission has approved a new formulation ofLevitra
(vardenafil HCI). Levitra 10mg
orodispersible tablet will be the first erectile dysfunction(ED)
medication available in this novel and
convenient formulation. In contrast to other drugs of the same
class, Levitra 10mg orodispersible tablet
allows men a discreet and convenient intake without water,
dissolving on the tongue within seconds with
a minty flavour. In Europe the launch roll-out will start as of
November 2010. In the United States the
medication has been approved in June 2010 and will be marketed
by GlaxoSmithKline and Merck & Co.,
Inc. under the tradename STAXYN.
"Bayer Schering Pharma is committed to men's health and
continuously striving to find new and
innovative treatment options in the treatment of erectile
dysfunction," said Dr. FlemmingOernskov, Head
of the Business Unit Women's Healthcare and General Medicine at
Bayer Schering Pharma in Berlin. "As
part of these efforts, we believe men with ED will appreciate a
convenient and easy to take medication.
Levitra orodispersible tablet allows men with ED to be prepared,
anytime, anywhere. This should help to
bring spontaneity into the sex life of men with ED."
The overall efficacy and safety of vardenafil has been widely
demonstrated in numerous clinical trials (1 -
10). For this registration, Levitra 10mg orodispersible tablet
was tested in the Phase III multinational trials
POTENT I and II (Pivotal phase III trial to investigate the
efficacy and safety of an Orodispersible Tablet
vardenafil versus placebo in the treatment of men with Erectile
dysfunction: a f ixed-dose, double-blind,
raNdomized multicenter Trial). These pivotal studies compared
the efficacy and safety of 10mg
vardenafilorodispersible tablet with placebo after 12 weeks of
treatment in a general population of men
with ED. These two international twin studies were conducted
with identical study design, enrolling a total
of 882 men above the age of 18 years who had ED for more than 6
months. (11,12), For both POTENT I
and POTENT II studies, vardenafilorodispersible therapy was
statistically significantly superior to placebo
for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy
measures (all p
