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10/21/2013 6:50:01 AM
Cubist Announces FDA Approval for Expanded Use of ENTEREG®
LEXINGTON, Mass.--(BUSINESS WIRE)-- Cubist Pharmaceuticals, Inc. (CBST) today announced the approval of its supplemental new drug application (sNDA) by the U.S. Food and Drug Administration (FDA) for ENTEREG® (alvimopan). The sNDA approval expands the indication for the use of ENTEREG to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis (i.e., re-connection of the bowel following removal of the resected segment).
Primary support for this expansion was a Phase 4 randomized, placebo-controlled, double-blind trial in patients undergoing radical cystectomy, an extensive surgical procedure that includes resecting a segment of the bowel to reconstruct the lower urinary tract. The original indication was supported by trials in patients undergoing bowel resection for benign or malignant colorectal or small bowel disease.
“Delayed GI recovery is one of the most common causes of prolonged hospital stays in patients undergoing major abdominopelvic surgery. We are pleased that doctors will have the option to help speed GI recovery for appropriate patients who have undergone surgeries that included a bowel resection,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “At Cubist, we are committed to improving patient outcomes within the hospital setting, and enabling patients to leave the hospital sooner through the use of therapeutics that help put them on the path to good health.”
The FDA originally approved ENTEREG in 2008 to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis. To date, ENTEREG is the first and only FDA-approved agent for this use. For full prescribing information, visit www.ENTEREG.com.
ENTEREG 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 surgeries that include partial bowel resection with primary anastomosis.
Important Safety Information
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.) REMS 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, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction The most common adverse reaction (incidence =1.5%) occurring with a higher frequency than placebo among ENTEREG treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). 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 Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.
Cubist and ENTEREG are registered trademarks of Cubist Pharmaceuticals, Inc.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding the therapeutic potential of ENTEREG, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: our ability to successfully commercialize ENTEREG; competitive risks from current and future therapeutic alternatives to ENTEREG; manufacturing issues related to supply of ENTEREG; our ability to maintain and enforce patent and other intellectual property protection for ENTEREG and those additional factors discussed in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this presentation, and we undertake no obligation to update or revise any of these statements.
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
Jennifer Baird, 781-860-1282
Director of Product Communications
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