From: trigonometry1972 on
Phase 2b study of arbaclofen placarbil for treatment of GERD
October 19 2009
XenoPort announced it has initiated a Phase 2b clinical
trial of arbaclofen placarbil, also known as XP19986,
in patients with gastroesophageal reflux disease (GERD)
who remain symptomatic despite treatment with a proton
pump inhibitor (PPI). This trial is a multi-center, randomized,
double-blind, placebo-controlled study designed to assess the
efficacy and safety of AP as adjunctive therapy to PPIs. XenoPort
expects to enroll approximately 425 subjects in this trial, which is
being conducted in the United States and Canada. Subjects with
a history of incomplete response to a PPI will undergo a f
our-week run-in on PPI therapy followed by a six-week
treatment period on PPI therapy plus either 20 mg or 40 mg
of AP dosed once daily, 20 mg or 30 mg of AP dosed twice
daily or placebo. The primary endpoint of the study will
examine heartburn events. Regurgitation will be assessed
as a key secondary endpoint.

AP (arbaclofen placarbil) is a Transported Prodrug of R-baclofen
that is designed to engage natural nutrient transport mechanisms
found on intestinal cell membranes, thereby gaining efficient
entrance into the bloodstream. AP is then rapidly converted
by high-capacity enzymes to R-baclofen and natural
substances that have well-studied, favorable safety
characteristics. R-baclofen is an agonist of a target
known as the gamma amino-butyric acid(B),
or GABA(B), receptor. Racemic baclofen
(a mixture of R and S isomers) has been approved
for the treatment of spasticity and has been shown in
clinical studies to have efficacy in a number of other
therapeutic indications, including GERD.

For more information call (408) 616-7200
or visit www.XenoPort.com.

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I hope this drug is safer than Reglan an earleir
motility med.