The approval of LINZESS 72 mcg is based on results from a Phase III clinical trial of 1,223 adults with CIC. "LINZESS is the branded prescription market leader in the treatment of adult patients with IBS-C or CIC, and we believe the availability of a 72 mcg dose will enhance the product's utility to physicians in treating patients across the broad CIC patient population, which encompasses up to 35 million adult Americans," said Tom McCourt, Chief Commercial Officer at Ironwood.īill Meury, Chief Commercial Officer at Allergan, said, "This approval is testimony to the ongoing commitment of our organizations to continue to innovate with LINZESS and to enhance patient care and refine the treatment of gastrointestinal disorders such as CIC." Since the launch of LINZESS in December of 2012, nearly 1.5 million unique patients have filled nearly 7 million prescriptions, according to IMS Health data. LINZESS is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults with CIC. The new dose is expected to be available in the first quarter of 2017.
The newly approved dose will provide physicians with dosing flexibility based on individual presentation or tolerability, in treating the large and heterogenous population of adult CIC patients. Food and Drug Administration (FDA) has approved a 72 mcg dose of LINZESS ®(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. 26, 2017 /PRNewswire/ - Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced today that the U.S. You dont know how horrible it feels to not be able to use the bathroom until you cant do it.CAMBRIDGE, Mass. and DUBLIN, Jan. I feel so much better now thanks to this wonderful little drug. You may need to work on the dosage because I had diarrhea at first but that is not a problem now that I am on a somewhat lower dose. Linzess really works and I go to the bathroom without trouble now. I tried laxatives and the fiber cereals and nothing was doing the trick. I have been suffering from constipation since I graduated from high school. Thank you! I do have to make some effort to use the bathroom at regular times now but I am willing to pay that price just to have the ability to use the bathroom again!
After I took Linzess I was able to go to the bathroom more often and the bloated feeling is gone and so is the sluggishness. I used the toilet maybe once in over a week. I was suffering badly from being constipated.
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