The most frequently reported treatment-emergent adverse events in the trial were hypokalemia, anemia, and postoperative ileus. The rate of postoperative ileus was 19.3% higher in the placebo-treated group compared to the ENTEREG-treated group. The incidence of all other treatment-emergent adverse events 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, blinded cardiovascular adverse events were adjudicated by an external independent clinical committee. The incidence of cardiovascular events was 15.3% percent for placebo-treated patients and 8.4% for ENTEREG treated patients, which was not statistically different (p=0.09).About ENTEREGENTEREG was approved in the United States in 2008. It is a peripherally acting µ-opioid receptor antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Because of concerns that long-term use of alvimopan may be associated with an increased risk of myocardial infarction, ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG, and ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, or in patients undergoing surgery for correction of complete bowel obstruction. The most common adverse reactions in patients treated with ENTEREG (incidence ≥3% with ENTEREG and at least 1% greater than placebo) undergoing bowel resection were anemia, dyspepsia, hypokalemia, back pain, and urinary retention. For more information on ENTEREG, including its full prescribing information, the Boxed Warning regarding short-term hospital use and the E.A.S.E.® Program, visit www.ENTEREG.com.
Cubist Submits ENTEREG Supplemental NDA
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