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  1. Hello together, for about 15 years I had problems about having diarrhea and the need to poop in stressful situations. If there was a long line, in the supermarket, in a traffic jam, at immigration counters on airports, all my body got hot, I had to fart really often and ended very often in the urgent need, to use a toilet. I think most of you know those situations, when you suddenly need a toilet, because you get stressed from the situation "What if I need a toilet soon?" ; and then you really need it! I had two colonoscopys, everything was perfectly fine, nothing bad. The doctors tried all different medications with me: Duspatal, MCP, Imodium (which worked best of all the doctors tried on me), but nothing worked properly. Imodium was okay, but the next day I could not poop and then it was really painful, when it was possible again. So I was fighting for years with the IBS-D and nothing helped. On activities with friends, I always had a good excuse, to say either, that I will not go with them or if we don't better want to stay at home / in a restaurant, it is more cozy...Even if my thought was obviously: There you have a toilet and feel safe! Now I was travelling one time to south america, where you can buy in the pharmacies almost everything you want, without prescription and I also bought Tramadol. Normally only wanted to have it as spare-medicine for really strong pain, but tried it one day just "for fun" and realized: It works amazing for my IBS-D. The Tramadol makes your head completely like: "I don't care! If I need to make a shit next to all the cars in the traffic jam, who cares? ; If the line in the supermarket is really long, I just leave the things, go to toilet and come back again". And I am super happy about it. Because now, in 95% of the days I am taking Tramadol (and I only take it on "special days", where I want to do activities), it works still perfect. Two hours before the activity taken just 50-100mg, and I am fine for about 12 hours. An absoloutely miracle drug for me. Now I am doing that already for about one year, didn't have to increase the dose and still love the effect of it. Before, flying on airplanes, was horror for me. I always took the flights in the afternoon, used the toilet all day several times, took Imodium, Buscopan and was still nervous about the need for a toilet. Now it is much less complicated and I don't have to care anymore. So, just as idea for the ones of you with IBS-D, give Tramadol a try. In Europe unfortunately almost only available by prescription (I never discussed that with my doctor yet, fortunately still have enough pills from holidays at home). In Southamerica and Asia, available OTC, for just a few bucks (2-5€ for 10 pills). They have several generics on the the market. The only downsides: Low sex drive, I almost cannot finish, when I am having sex after taking tramadol and cannot sleep properly, when taking it "shortly" before sleep ; you feel all night like being "up" and doing daydreaming. But for me, it is worth those problems on special days, to enjoy time with friends. Maybe it is also a miracle drug for one of you, that you don't have to suffer for so long, like me. I now really can enjoy life again, go for walks, without having in my head "What, if I need toilet on the walk?". Cheers
  2. IBS Quality of Life and Risk Survey Please complete this 1-minute, 4-question survey for us that will help us prepare for our presentation to an FDA Advisory Committee meeting next month. Thank you! https://www.surveymonkey.com/r/B6Z67VP
  3. There will be a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee at the Food and Drug Administration (FDA) on October 17, 2018. Agenda: The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease. The IBS Patient Group will be submitting a comment for the public docket for this meeting. If you have experience with Zelnorm for IBS-C or CIC when it was first marketed by Novartis Pharma in 2002 - 2007, we would like to hear from you. Please email us at ibs@ibspatient.org or add your comments below. https://www.federalregister.gov/documents/2018/09/11/2018-19669/joint-meeting-of-the-gastrointestinal-drugs-advisory-committee-and-the-drug-safety-and-risk
  4. Synergy Pharmaceuticals Announces FDA Approval of TRULANCE® (Plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the U.S. Food and Drug Administration (FDA) has approved TRULANCE® (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for TRULANCE, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC). TRULANCE is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, with or without food, at any time of the day. TRULANCE is packaged in a unique, 30-day calendar blister pack. “Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options,” said William D. Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan. “With this second indication for TRULANCE, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.” “The TRULANCE label reflects the strong and remarkably consistent efficacy and safety profile TRULANCE has demonstrated in treating over 4,700 patients across both CIC and IBS-C clinical trials,” said Patrick H. Griffin, MD, Chief Medical Officer of Synergy. “To-date, real world patient experience has supported the clinical trial data, highlighted by a post-marketing diarrhea rate of less than 0.5% and no reports of severe diarrhea requiring hospitalization since the launch of the TRULANCE CIC indication. The IBS-C approval today builds on the already strong CIC label and further establishes TRULANCE as the first and only uroguanylin analog.” With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to human uroguanylin and is the only treatment thought to replicate the pH-sensitive activity of uroguanylin. TRULANCE Phase 3 IBS-C Program Design The Phase 3 IBS-C program included two randomized, 12-week, double-blind, placebo-controlled trials evaluating the efficacy and safety of TRULANCE in adult patients with IBS-C. Across the two trials, more than 2,100 patients received a once-daily tablet of TRULANCE (3 mg or 6 mg doses) or placebo. Both trials included a two-week, pre-treatment baseline period, a 12-week treatment period, and a two-week, post-treatment follow-up period. Patients who were enrolled in these trials fulfilled Rome III IBS-C criteria related to abdominal pain and stool changes. The company only sought approval for the 3 mg dose. Primary Endpoint The primary endpoint for both trials was the percentage of patients who are Overall Responders during the 12-week treatment period. An Overall Responder, as defined by the FDA, was a patient who fulfilled both ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) from baseline, in the same week, for at least 50% of the 12 treatment weeks. Results In both Phase 3 IBS-C trials, TRULANCE met the primary endpoint as compared with placebo (Study 1: 30.2%; 17.8% in placebo; p<0.001. Study 2: 21.5%; 14.2% in placebo; p=0.009). In both studies, patients who received TRULANCE experienced significantly reduced abdominal pain and improvements in stool frequency, stool consistency, and straining with bowel movements during the 12-week treatment period as compared to placebo. In both studies, the most common adverse event was diarrhea (4.3%; 1.0% at placebo), with severe diarrhea reported in 1% of patients. Overall discontinuation rates were low among patients treated with TRULANCE and placebo (2.5%; 0.4% at placebo) and the most common adverse reaction leading to discontinuation was diarrhea (1.2%; 0% in placebo). Indications and Usage TRULANCE (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C). IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS TRULANCE® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of TRULANCE have not been established in pediatric patients less than 18 years of age. Contraindications TRULANCE is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. TRULANCE is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients TRULANCE is contraindicated in patients less than 6 years of age. The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences. Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. Diarrhea Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of TRULANCE-treated CIC patients, and in 1% of TRULANCE-treated IBS-C patients. If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient. Adverse Reactions In the two combined CIC clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo). In the two combined IBS-C clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo). Please also see the full Prescribing Information, including Box Warning, for additional risk information. About Irritable Bowel Syndrome with Constipation (IBS-C) Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with two or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent. About Chronic Idiopathic Constipation (CIC) CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety. About TRULANCE® TRULANCE® (plecanatide) is a once-daily tablet approved for adults with CIC or IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function. About Synergy Pharmaceuticals Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com. Contacts: Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP, Investor Relations and Corporate Communicationsghopkins@synergypharma.com
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