CUBIST ANNOUNCES FDA APPROVAL FOR EXPANDED USE OF ENTEREG®

October 21, 2013

New Label to Provide Expanded Use Following Surgeries That Include a Bowel Resection with Primary Anastomosis

Lexington, Mass., October 21, 2013 Cubist Pharmaceuticals, Inc.  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.

 

About ENTEREG

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.

 

About Cubist

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.

 

BioFlash

Membership Deliverables

MassBio Membership gives you:

Purchasing power-MassBio negotiates a broad-based collection of services on behalf of member companies and passes the savings on to its members. 

Networking and professional development-MassBio organizes and executes numerous conferences, committee meetings, and networking events throughout the year.

MassBio Signature Events-Attend our Investors Forum, Innovator Roundtables, Pharma Days, our Golf Classic Fundraiser, Policy Leadership Breakfast, and many others.

Public policy & Advocacy-As the state's leading advocate for our life science super cluster, we fight for public policy initiatives and tax incentives in Massachusetts and Washington, D.C., that will enable biotechnology companies to do their best work.

Economic development-MassBio provides expert advice and guidance to help companies find suitable locations and resources as they move to and grow in the Bay State. We make Massachusetts a better place for your business.

Visibility/Resources-Members are listed on a searchable directory that includes a profile and link to the company's website. We highlight your company's latest news by posting to our MassBio member news page. In addition, members can post job openings on our website free!

Educational incentives-We promote education, workforce development and lifelong learning through the MassBioEd Foundation. The foundation customizes training programs for companies and educational institutions and promotes science in the classroom through BioTeach. MassBio members receive a discount on courses offered by the foundation.