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Cubist (CBST): Entereg Phase 4 Study In Patients Undergoing Radical Cystectomy Met Primary Endpoints

 April 17, 2012 08:09 PM

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.

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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.

The 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.

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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 in severity.

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 radical cystectomy.

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.

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