Antares Pharma Announces Positive Top Line Results From Its Pivotal Phase 3 Study of Anturol Gel for the Treatment of Overactive Bladder
Business Wire, July 27, 2010
– Company on Target to File NDA in 2010 -
EWING, N.J. — Antares Pharma, Inc. (NYSE Amex:AIS) announced today positive results
from its Phase 3 study of AnturolTM Gel in patients with
overactive bladder (OAB). The study met its primary endpoint of a
statistically significant reduction in urinary incontinence episodes for
both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033
respectively). An Open Label Extension study, evaluating long term
safety remains ongoing and is scheduled to complete by Q4 2010.
The Phase 3 trial conducted under a Special Protocol Assessment (SPA)
with FDA was a double blind, randomized, parallel placebo-controlled
multi-center study and evaluated the efficacy and safety of Anturol in
600 patients with overactive bladder. The primary objective of the study
was to demonstrate that daily treatment of an 84mg or 56mg dose of
oxybutynin applied in the ATDTM Gel technology for 12 weeks
was superior to placebo for the relief of OAB symptoms.
Paul. K. Wotton Ph.D., President and Chief Executive Officer of Antares
said This success represents another key accomplishment in 2010 and
continues to demonstrate our strong development capabilities. Anturol is
one of many value drivers in our advancing pipeline of development
products. We are delighted with the positive outcome of this Phase 3
trial, as both doses demonstrated a statistically significant reduction
in the primary endpoint of urinary incontinence events as well as a low
incidence of reported side effects. We are on track to file a new drug
application (NDA) with the FDA in 2010.
Roger R. Dmochowski M.D., FACS, Professor, Vanderbilt University,
Department of Urologic Surgery stated Anturol potentially offers many
advantages for the treatment of OAB. Anturol is dispensed in a patient
friendly metered dose pump which provides convenient dosing options.
Both doses tested in the Phase 3 trial demonstrated a low incidence of
side effects and the data also show that Anturol effectively reduces
urinary incontinence episodes within seven days of beginning treatment
compared to placebo.
Secondary end points included changes from baseline in average daily
urinary frequency, void volume, patient perceptions, as well as safety
and tolerability including skin irritation
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