Cubist Pharmaceuticals, Inc. CBST today announced that it has
submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug
Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan)
to accelerate GI recovery following any surgery that includes a bowel
resection with primary anastomosis; expanded from the current indication in
patients requiring surgery for colorectal disease.
This proposed label modification is derived from a recently completed
randomized, double-blind, placebo-controlled, Phase 4 clinical trial of
patients undergoing radical cystectomy for bladder cancer, an extensive
surgical procedure that includes resecting a segment of bowel to reconstruct
the lower urinary tract. This study, in conjunction with the original clinical
trial data, forms the body of evidence supporting the request for expansion of
the current indication.
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