U.S. Food and Drug Administration Approves Linaclotide (Linzess) for IBS with Constipation
UPDATE: June 9, 2013– As of mid-May 2013, Constella is available to be prescribed in the United Kingdom. See the May 22, 2013 article by Pharma Times Online Thank you to Dr. Barbara Bradley Bolen, About.com IBS Guide for alerting us to this news.
UPDATE: On December 17, IFFGD posted that linaclotide (Linzess) is now available for prescription in U.S. pharmacies.
UPDATE: On November 28, 2012, Ironwood Pharmaceuticals and Almirall S.A. reported that linaclodtide has been approved for marketing in Europe. It will be known in that region as Constella. Projected availability is the first half of 2013. See the November 30, 2012 post.
UPDATE: On September 21, 2012, IFFGD posted that Ironwood Pharmaceuticals and Almirall, S.A., the company licensed to market linaclotide in Europe, report that the European Committee for Medicinal Products for Human Use (CHMP) has issued a recommendation that linaclotide be approved for prescription to adults with moderate to severe irritable bowel syndrome with constipation (IBS-C). This medication, to be known in Europe by the brand name Constella, still awaits approval by the European Commission, but this recommendation represents progress in the final stages toward linaclotide’s approval and availability in Europe. No projected date is known at this time. Here is IFFGD’s original announcement on Constella.
Earlier this week, the U.S. Food and Drug Administration approved the use of linaclotide for use in treating chronic idiopathic constipation or irritable bowel syndrome with constipation in adults, 18 and older, both men and women. The new medication, which is an oral capsule to be taken once a day, is to be marketed jointly by Ironwood Pharmaceuticals and Forest Laboratories and will be known in the U.S. as Linzess. Linzess has not received FDA approval for use in children ages 17 or younger.
According to About.com IBS Guide Barbara Bradley Bolen’s recent blog post on linaclotide, the medication is still undergoing the approval process in Europe, where the brand name is Constella. In addition, material directly from Ironwood Pharmaceuticals indicates that Ironwood has licensed linaclotide to another pharmaceutical company for potential use in several countries in Asia, but no information has been given at this time as to the current status of clinical trials or approval in that region of the world. Both of the above linked sources include a brief explanation of what the medication is and how it is believed to work. The original FDA press release on Linzess is linked here. The New York Times, via Reuters, reports that Linzess is expected to be available for physicians to prescribe “in the fourth quarter,” apparently meaning by the last few months of this year.
As many in the IBS community are aware, FDA-approved prescription medications specifically for irritable bowel syndrome of any subtype are extremely limited, and no single treatment, whether it is medication, diet, psychological interventions, or others, proves appropriate or effective for every individual with IBS, even those with similar symptom patterns. It has been several years since a new prescription IBS drug was last made available. IBS Impact is pleased that those with constipation-predominant IBS will soon have another option, and urges those who are considering Linzess to read the available information, to familiarize themselves with the benefits and risks and to consult their own doctors as to if Linzess is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular treatments, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.