August 6, 2009
Phase II study results of HOB-294 (transdermal oxybutynin hydrochloride)for
treatment of overactive bladder
In this report Hisamitsu Pharmaceutical Co. Ltd. (Hirotaka Nakatomi, President &
Chief Executive Officer) publishes the domestic phase II study results of HOB-294
(transdermal oxybutynin hydrochloride) under development for treatment of overactive
bladder.
HOB-294 is a transdermal product containing oxybutynin hydrochloride intended for
treatment of "overactive bladder" with symptoms such as micturition urgency and
pollakiuria.
HOB-294, under development in Japan, is expected for long-term efficacy by
maintaining of stable blood drug concentrations and decreased incidence of
metabolite-induced adverse drug reactions by avoiding the liver first-pass effect, which
are benefits of the characteristics of the transdermal formulation.
This phase II clinical study was an 8-week placebo-controlled double-blind study in
patients with overactive bladder. HOB-294 or placebo was administered once daily in
this study with a primary endpoint of improvement of symptoms.
The data analysis confirmed dose-response of HOB-294 and demonstrated a
statistical difference of improvement in the primary endpoint of efficacy between the
HOB-294 and placebo groups. For safety no serious adverse event was observed.
Based on these results Hisamitsu will advance to the subsequent phase III clinical
study.