U.S. Food and Drug Administration Seeks Public Comment on Prucalopride for Chronic Idiopathic Constipation (CIC) and Tegaserod for Irritable Bowel Syndrome with Constipation (IBS-C) by October 16, 2018

UPDATE:  10/19/2018: The Gastrointestinal Drugs Advisory Committee voted to recommend approval of both of the medications under consideration below. This does not mean that the medications have the full approval of the FDA and can be made available yet. However, it is a positive step forward in the process toward full approval.

 

On Wednesday, October 17, 2018, from 8:00 a.m. to 5:00 p.m at the Bethesda Marriott in Bethesda, Maryland, the U.S. Food and Drug Administration (FDA) he Food and Drug will hold a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to consider the safety and effectiveness of two medications, prucalopride, intended for treatment of Chronic Idiopathic Constipation (CIC), and tegaserod, intended for treatment of irritable bowel syndrome with constipation (IBS-C). Manufacturers are seeking FDA approval to make both available in the United States.

Prucalopride, a selective serotonin type 4 receptor agonist, has been in use for several years in Canada under the brand name Restoran and in various European countries as Resolor. Tegaserod (brand name Zelnorm), a selective serotonin type 4 receptor partial agonist was available  in the United States and Canada from 2002-2007, when the FDA and  Health Canada, each asked for its withdrawal due to many reports of serious side effects, including unstable angina and strokes. Since then, the FDA has only made Zelnorm available on a rare emergency basis after a physician application for specific individual patients. The current FDA application, if successful, would return Zelnorm to market in the U.S. only for women without risk factors for cardiovascular complications.

The Committee is seeking comments from the gastrointestinal disorders community before midnight Eastern time on October 16. 2018. Electronic comments may be submitted here for tegaserod (Zelnorm), with the understanding that all identifying and health information included in comments will be publicly accessible on the Internet. Those wishing to comment confidentially are asked to submit two identical copies paper documents with a cover sheet stating, “This document contains confidential information.” by mail, courier or hand delivery to : Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The FDA will add all information not specifically indicated as confidential to the public docket.  All comments for Zelnorm must be marked with the following docket: Docket No. FDA-2018-N-3223 for “Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

The instructions for comments on prucalopride are similar with a different electronic link here and a different identifying docket number that must be placed on comments, Docket No. FDA-2018-N-0055 for “Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

IBS Impact encourages U.S. readers to familiarize themselves with the above medications so that they can make informed comments. This is an opportunity to communicate the needs of the gastrointestinal disorders community directly to a committee of the FDA that can make recommendations before or against approval.  There are only a few days remaining before the deadline, so act now.

 

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