Zydena is Efficacious in Once Daily Dosing for Erectile Dysfunction/Positive BPH Results
Data to be presented at 12th Congress of the European Society for Sexual Medicine, November 15th to 18th, Lyon
SEOUL, South Korea, Nov. 18 /PRNewswire/ -- Dong-A
Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced
today that it has completed a 240 patient once-a-day dosing
clinical study of udenafil, its new long acting phosphodiesterase
type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The
multi-center study conducted in Korea was a randomized,
double-blind, placebo-controlled study, designed to investigate the
efficacy and safety of udenafil in patients with ED. Following a
4-week non-drug baseline period, 240 men with ED of broad etiology
and severity were randomized to one of four treatment groups:
Placebo, udenafil 25 mg, udenafil 50 mg or udenafil 75 mg. Patients
took one tablet a day for 12 weeks with evaluations every 4 weeks.
The primary efficacy endpoint was the change in the standard
International Index of Erectile Function (IIEF) Erectile Function
Domain (EF) score from baseline to final visit. The secondary
efficacy endpoints were the change from the baseline in the mean
vaginal penetration success rates and mean intercourse completion
rates calculated from the Sexual Encounter Profile (SEP) questions
2 and 3. In addition a sub-group analysis was conducted to
determine efficacy in the patients that had lower urinary tract
symptoms associated with benign prostatic hyperplasia in addition
to erectile dysfunction.
The primary efficacy endpoint for the 50 mg and 75 mg doses were
statistically significant compared to placebo. The mean vaginal
penetration success rates at 12 weeks (final visit) were 98.7%
(75mg) and 90.3% (50mg) and both dose levels were statistically
significant compared to placebo (p<0.01). The change from
baseline to final visit in the mean intercourse completion rates
were 73.5% (75mg) and 51.4% (50mg) significantly (p<0.0001)
higher compared to the 23.5% observed in the placebo group.
Patients reporting improved erections after the 12-week course of
therapy were 88% (75mg), 75% (50mg) and 69.5% (25mg) and
significantly (p<0.0001) higher compared to 35.6% in the placebo
group. Forty-four percent of the patients in the 75 mg group
shifted to normal erectile function (EF domain scores > 25)
after 12 weeks on drug compared to 13.6% in the placebo
group.
Approximately 65% in this ED trial also had lower urinary tract
symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
as assessed by the validated International Prostate Symptom Score
(IPSS) questionnaire. Efficacy for the relief of lower urinary
tract symptoms due to BPH was achieved consistently in a dose
dependent manner.
All three active dose levels were well-tolerated; the most
frequently reported Treatment-emergent adverse events were flushing
and headache and were mostly mild to moderate in severity. No
myalgia, back pain, leg pain or vision disturbances were reported
and no serious adverse events related to the drug were
reported.
"We are extremely pleased with the results of this trial which
clearly demonstrated the excellent efficacy and safety of
Zydena® when taken once a day for erectile dysfunction and
potentially for other more chronic indications. The efficacy trend
seen for the relief of LUTS was also a plus", commented Mr. Dong
Hyun Park, President and CEO of Dong-A PharmTech. Mr. Park
indicated that Dong-A PharmTech will initiate a development program
for the treatment of LUTS associated with BPH and for pulmonary
arterial hypertension in early 2010 in the USA.
Dr. Ridwan Shabsigh, a leading urology researcher in the USA
commented, "the results indicate that Zydena® is efficacious
for ED at once daily dose levels of 50 mg and 75 mg, and the
analysis of the IPSS in the men having LUTS presents the potential
for the use of Zydena® as a once a day treatment for LUTS
associated with BPH".
Also commenting is Dr. Jae Seung Paick, a member of the Board of
Chairman at Societe Internationale d'Urologie. Dr. Paick commented
that "developing long-acting PDE-5 inhibitors for LUTS associated
with BPH is gaining a strong momentum. Udenafil, given its
favorable efficacy and side effect profile is an excellent
candidate for this new exciting therapeutic option for this
troublesome condition affecting many of my patients."
Zydena® is currently marketed in Korea and Russia. About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech is a late-stage pharmaceutical company
incorporated in Korea, focused on the development and
commercialization of udenafil in North America and Russia and a
number of other novel compounds globally.
Statements under the Private Securities Litigation Reform Act:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risk and uncertainties that may
individually or mutually impact the matters herein described,
including but not limited to FDA review and approval, product
development and acceptance, manufacturing, competition, and/or
other factors, which are outside the control of the Company.
Mr. Won Geun KIM General Manager Tel: +82 2 560 8008 Fax: + 82 2 563 6517 Email: wgkim@donga.co.kr
Source: Dong-A PharmTech Co. Ltd.
CONTACT: Mr. Won Geun KIM, General Manager of Dong-A PharmTech
Co. Ltd.,
+82 2 560 8008, fax, + 82 2 563 6517, wgkim@donga.co.kr
