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Drug pipeline is flush with new options for chronic constipation
npg 2012 Nature America, Inc. All rights reserved.
Felicia Avella has suffered from irritable bowel syndrome (IBS) all her life. Over the years, she has tried numerous drugs to deal with the painful constipation that goes along with her gastrointestinal disorder, but nothing has seemed to provide relief. Then, three-and-a-half years ago, at the age of 61, Avella signed up for a clinical trial testing a new agent called linaclotide, an experimental peptide designed to increase bowel movements in people with chronic constipation. It just changed my life, she says. I didnt know what normal was until I started on the drug.
Since the trial ended and the drug was taken away from her, Avella, a retired accountant from Englewood, Florida, has had to rely on an over-the-counter laxative. This drug has helped with her constipation issues, but it hasnt provided any reprieve from her abdominal discomfort or bloating. Thus, if the US Food and Drug Administration (FDA) approves linaclotide, as most experts think it will, Avella says shed be the first person lined up at her gastroenterologists office to discuss switching back to the more targeted agent. A regulatory decision on linaclotide, developed by Ironwood Pharmaceuticals of Cambridge, Massachusetts, in collaboration with New Yorks Forest Laboratories, is expected sometime this month.
Long-term constipation is a commonly occurring ailment that affects approximately 15% of the US population, resulting in 2.7 million physician visits and 38,000 hospitalizations each year. The first drug ever approved by the FDA for the treatment of chronic idiopathic constipation (CIC) and IBS with constipation was a serotonin receptor activator called tegaserod, which Novartis began selling as Zelnorm in 2002. The Swiss pharma giant pulled the anticonstipation agent five years later, however, after studies linked the drug with an increased risk of heart disease. That has left only lupiprostone, a chloride channel activator marketed as Amitiza by Japans Sucampo Pharma and Takeda Pharmaceuticals, for the treatment of lasting bowel problems. Amitiza gained US approval in 2006 and earned $226 million last year in domestic sales alone.
Like lupiprostone, linaclotide works to increase fluid secretion into the gut by stimulating chloride channels in the inner lining of the intestineswhich...