Cubist Pharmaceuticals Inc. (NASDAQ:CBST) said a Phase 4 study of
Entereg (alvimopan) in patients undergoing radical cystectomy met its
primary endpoint of time to achieve recovery of both upper and lower
gastrointestinal (GI) function.
In this study, the adverse event profile was comparable between
Entereg and placebo. This study was a post-approval commitment with the
U.S. Food and Drug Administration (FDA). The company expects to submit a
supplemental New Drug Application by the end of 2012.
All secondary endpoints, including length of hospital stay, also
achieved statistical significance. Delayed recovery of GI function is
one of the most common complications prolonging hospital stay in
patients undergoing radical cystectomy.
The accelerated recovery of GI function and associated reduction in
length of stay suggests that Entereg has the potential to improve
surgical outcomes for patients undergoing radical cystectomy.
Phase 4 investigation was a randomized, double-blind, placebo-controlled
study of Entereg 12 mg or placebo administered by mouth once
preoperatively and twice daily (BID) postoperatively for a maximum of 15
hospital doses in 280 patients undergoing radical cystectomy.
Assessments for efficacy were performed over a 10-day observation period
and safety evaluated through 30 days after the last dose of study drug.
The most frequently reported treatment-emergent adverse events in the
trial were hypokalemia, anemia and postoperative ileus. The rate of
postoperative ileus was higher in the placebo-treated group compared to
the Entereg-treated group.
The incidence of all other treatment-emergent adverse events,
including hypokalemia and anemia, was comparable between the two groups.
The majority of treatment-emergent adverse events were mild or moderate
The incidence of severe treatment-emergent adverse events was
comparable between the two treatment groups. In this study,
cardiovascular adverse events were adjudicated by an external
independent clinical committee. The incidence of cardiovascular events
was 15% for placebo-treated patients and 8.4% for Entereg-treated
patients, which was not statistically different.
Radical cystectomy is a major abdominopelvic surgical procedure
performed on patients with urinary bladder cancer. Delayed recovery of
GI function is one of the most common complications associated with
This procedure generally involves removal of the urinary bladder and
associated organs within the pelvis as necessary. The primary goal of
radical cystectomy is to resect local and locally metastatic disease
with functional urinary tract reconstruction.
CBST closed Tuesday's regular trading up 0.80% at $40.22. The stock
has been trading between $28.82 and $44.95 for the past 52 weeks.