Claim: FDA approves irritable bowel drug.
Verdict: SUPPORTS

Retrieved passages:
title: Alosetron
text: for Drug Evaluation and Research is funded by user fees paid by pharmaceutical manufacturers, and that the reinstatement of alosetron was negotiated in confidential meetings with representatives of GlaxoSmithKline. An article published in the British Medical Journal (BMJ) noted: "By allowing the marketing of alosetron, a drug that poses a serious and significant public health concern according to its own terms, the FDA failed in its mission." Others have argued that the approval process of Lotronex was an example of regulatory capture. Alosetron is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who have: Severe IBS-D includes:

title: Renzapride
text: one drug, metoclopramide, dopamine D2 receptor antagonist, is FDA approved for the treatment of gastroparesis in the US. Patients treated with metoclopramide are at risk for serious side effects, some of which are permanent, such as tardive dyskinesia, hence limiting the use of metoclopramide to no more than 12 weeks. Renzapride was being investigated for the treatment of constipation-predominant irritable bowel syndrome (IBS-C). It is also potentially effective for irritable bowel syndrome with alternating stool pattern (IBS-A). It is being developed by Alizyme plc of the United Kingdom. As of 23 April 2008, Alizyme ceased all development of renzapride, after

title: Tegaserod
text: Tegaserod Tegaserod is a 5-HT agonist manufactured by Novartis and sold under the names Zelnorm and Zelmac for the management of irritable bowel syndrome and constipation. Approved by the FDA in 2002, it was subsequently removed from the market in 2007 due to FDA concerns about possible adverse cardiovascular effects. Before then, it was the only drug approved by the United States Food and Drug Administration to help relieve the abdominal discomfort, bloating, and constipation associated with irritable bowel syndrome. Its use was also approved to treat chronic idiopathic constipation. The drug functions as a motility stimulant, achieving its desired

title: Tegaserod
text: tegaserod treatment. Currently, tegaserod may only be used in emergency situations only with prior authorization from the FDA. Tegaserod Tegaserod is a 5-HT agonist manufactured by Novartis and sold under the names Zelnorm and Zelmac for the management of irritable bowel syndrome and constipation. Approved by the FDA in 2002, it was subsequently removed from the market in 2007 due to FDA concerns about possible adverse cardiovascular effects. Before then, it was the only drug approved by the United States Food and Drug Administration to help relieve the abdominal discomfort, bloating, and constipation associated with irritable bowel syndrome. Its use

title: Alosetron
text: the approval of a supplemental New Drug Application (sNDA) that allows restricted marketing of Lotronex (alosetron hydrochloride), to treat only women with severe diarrhea-predominant irritable bowel syndrome (IBS). The strict prescribing guidelines initially introduced in 2002 were relaxed slightly in 2016, enabling electronic prescriptions among other benefits. It is not known whether alosetron has been filed for registration in the EU. GSK sold "Lotronex" to the Californian corporation Prometheus in late 2007. Since 2015, generic versions of alosetron have been available in the US, sold by a number of different companies including Actavis Pharma Company, Prometheus Laboratories and Sebela Pharmaceuticals

title: Plecanatide
text: including the CIC3 and National CIC3 trials. The latest Phase II trial for CIC concluded in March 2016. There have also been multiple Phase III trials for Plecanatide in its pursuit of an IBS-C indication, the latest of which was completed in June 2017. In January 2016, an NDA was filed with the FDA and by April a PDUFA action date had been assigned. As noted above, Plecanatide was approved for use in CIC in January 2017. A sNDA was filed in March 2017 to add an additional indication of irritable bowl syndrome with constipation (IBS-C) and a PDUFA date

title: Irritable bowel syndrome
text: other medications in this specific category. Benefits may include reduced diarrhea, reduced abdominal cramps, and improved general well-being. Any nausea present may also respond to 5HT3 antagonists owing to their antiemetic properties. Serotonin stimulates the gut motility and so agonists can help constipation-predominant irritable bowel, while antagonists can help diarrhea-predominant irritable bowel. Selective serotonin reuptake inhibitors, SSRIs, frequently prescribed for panic and/or anxiety disorder and depression, affect serotonin in the gut, as well as the brain. The bowels are highly dependent on serotonin for neural communication. "Selective serotonin reuptake inhibitor antidepressants seem to promote global well-being in some patients with

title: Alosetron
text: Alosetron Alosetron (original brand name: Lotronex ; originator: GSK) is a 5-HT antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in women only. It is currently marketed by Prometheus Laboratories Inc. (San Diego). Alosetron was withdrawn from the market in 2000 owing to the occurrence of serious life-threatening gastrointestinal adverse effects, but was reintroduced in 2002 with availability and use restricted. Alosetron was originally approved by the U.S. Food and Drug Administration (FDA) on February 9, 2000, after a seven-month review. At the time of the initial approval U.S. Food and Drug Administration (FDA) reviewers found

title: Lubiprostone
text: adults, as well as irritable bowel syndrome associated with constipation in women. Lubiprostone is approved to treat chronic idiopathic constipation (CIC) in adults. Lubiprostone is also approved to treat opioid-induced constipation, in adults with chronic non-cancer pain. The effectiveness of lubiprostone has not been established in patients who are taking a diphenylheptane opioid (e.g., methadone). Lubiprostone is approved to treat irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older. As of 12 November 2014, lubiprostone has not been studied in children. There is current research underway to determine the safety and efficacy in postoperative bowel

title: Linaclotide
text: Trulance, was approved by the FDA for the treatment of chronic idiopathic constipation (CIC), and is likewise an agonist of guanylate cyclase, except with hexadecapeptide structure. In 2017 the list price for linaclotide in the US was $378 for 30 pills and plecanatide was priced the same; Allergan and Ironwood increased the price of linaclotide to around $414 in 2018. Linaclotide Linaclotide (marketed under the trade name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause. It has a black box

title: Eluxadoline
text: eluxadoline with high fat meal decreased the C by 50% and AUC by 60%. The synthesis of eluxadoline was extensively discussed in the patent No. WO2006099060 A2, with the title : "Process for the preparation of opioid modulators" which was published in Sept. 2006 Eluxadoline Eluxadoline, sold under the brand names Viberzi ( ) in the US and Truberzi in Europe, is a medication taken by mouth for the treatment of diarrhea and abdominal pain in individuals with diarrhea-predominant irritable bowel syndrome (IBS-D). It was approved for use in the United States in 2015. The drug originated from Janssen Pharmaceutica

title: Biological therapy for inflammatory bowel disease
text: approved by the FDA. The advancements in biological therapy greatly changed how IBD is treated. Patients with Crohn's disease and ulcerative colitis show an increase in proinflammatory cytokines such as IL-1, IL-6, IL-8, IL-23, and TNF. In 1988, a monoclonal antibody called infliximab was discovered at New York University's School of Medicine. Infliximab works by binding to TNF, stopping its inflammatory effects. It was initially used for the treatment of Crohn's disease and it became the first FDA approved TNF inhibitor in 1998. Infliximab as well as other TNF inhibitors like adalimumab, certolizumab, and golimumab are currently the most common

title: Olsalazine
text: constipation-predominant irritable bowel syndrome that uses olsalazine and the anti-gout drug colchicine. Olsalazine Olsalazine is an anti-inflammatory drug used in the treatment of inflammatory bowel disease such as ulcerative colitis. It is sold under the name Dipentum. The chemical name is 3,3' -azobis (6-hydroxybenzoate)salicylic acid. It is sold as the disodium salt. Like balsalazide, olsalazine is believed to deliver mesalazine, or 5-aminosalicylic acid (5-ASA), past the small intestine, directly to the large intestine, which is the active site of disease in ulcerative colitis. Olsalazine gained Food and Drug Administration (FDA) approval in 1990. The drug is supplied by UCB Pharma.

title: Vedolizumab
text: was given a Priority Review Status, which functions to expedite potential acceptance to market. On December 9, 2013, the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) discussed the vedolizumab application for approval for both Ulcerative Colitis and Crohn's Disease under the trade name Entyvio. The voting went as follows: 1. Safety and efficacy data outweigh potential risks 21-0 2. In favour of UC treatment 21-0 3. In favour for CD treatment 20-1. Although GIDAC/DSaRM were a non-binding advisory committee, their opinions as field experts represent one of the last steps towards drug acceptance.

title: Rifaximin
text: be protected from generic formulations until March 24, 2017. Rifaximin is approved in 33 countries for GI disorders. On August 13, 2013, Health Canada issued a Notice of Compliance to Salix Pharmaceuticals Inc. for the drug product Zaxine. In India it is available under the brand names Ciboz and Xifapill. In Russia and Ukraine the drug is sold under the name Alfa Normix (Альфа Нормикс), produced by Alfa Wassermann S.p.A (Italy). Rifaximin Rifaximin, sold under the trade name Xifaxan among others, is an antibiotic used to treat traveler's diarrhea, irritable bowel syndrome, and hepatic encephalopathy. It has poor absorption when

title: Plecanatide
text: was set for January 2018. Plecanatide Plecanatide (brand name Trulance), is a drug approved by the FDA for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. Plecanatide is an agonist of guanylate cyclase-C. Plecanatide increases intestinal transit and fluid through a buildup of cGMP. As of January 2017, Plecanatide is approved in the United States for the treatment of chronic idiopathic constipation in adults. The presence of this condition is determined using the Rome III diagnostic criteria for chronic constipation which requires that the patient meet stool frequency, stool consistency, incomplete evacuation, and straining requirements

title: Alosetron
text: was associated with a 12% (CI 4.7-19.2) improvement in relief from abdominal pain and discomfort associated with diarrhoea-predominant patients. The prescription of alosetron is currently approved in the U.S. at 0.5 and 1 mg. The FDA Medical Officer's Review, dated November 4, 1999, noted: “Patients considered by investigators to fit the diarrhea-predominant subtype had at baseline… stool consistency values that were neither loose nor watery”. The FDA's Gastrointestinal Drugs Advisory Committee referred to the drug's efficacy as "modest", highlighting that the placebo brought relief on the primary outcome measure to 40–50% of women. Alosetron was withdrawn in 2000 following the

title: Linaclotide
text: Linaclotide Linaclotide (marketed under the trade name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause. It has a black box warning about the risk of serious dehydration in children in the US; the most common adverse effects in others are gastrointestinal. It is an oligo-peptide agonist of guanylate cyclase 2C and remains in the GI tract after it is taken orally. It was approved in the US and Europe in 2012. It is priced at around $400 for thirty pills

title: Biological therapy for inflammatory bowel disease
text: FDA-approved reference product." Currently, the only two biologic treatments for IBD that have approved biosimilars are adalimumab and infliximab. Biologics are known to sometimes cause harsh side effects. Currently, Biologics are only delivered systemically. They can't be delivered orally because the harsh environment of the gastrointestinal tract would breakdown the drug before it could reach the diseased tissue. Because systemic administration results in blockading the same pathway in both healthy and diseased tissue, pharmacology is exaggerated leading to many side effects such as lymphoma, infections, congestive heart failure, demyelinating disease, a lupus-like syndrome, injection site reactions, and additional systemic side

title: RosePharma
text: regulating GI and nutritional function. Rose Pharma currently works mainly in the research and development of its main drug, ROSE-010. ROSE-010 is a pharmaceutical therapy intended to treat pain symptoms of irritable bowel syndrome. The pharmaceutical, ROSE-010 mimics the hormone GLP-1 which modulates smooth muscle contractions and thus reduces spasms associated with IBS. ROSE-010 must be administered subcutaneously or intravenously. A phase II double-blinded placebo controlled trial in Europe demonstrated efficacy of this approach, and a phase I/II trial in the US established the safety of this concept also in IBS patients with predominant constipation. These clinical data, together with