All Boards >> Irritable Bowel Syndrome Research Library

HeatherAdministrator

Reged: 12/09/02
Posts: 7687
Loc: Seattle, WA
FDA approves new drug for chronic constipation
01/26/17 03:05 PM

FDA approves new treatment for chronic constipation

January 20, 2017

Trulance received FDA approval for the treatment of chronic idiopathic constipation, according to press releases from the manufacturer and the FDA.

The impact of chronic constipation on the lives of affected patients is often underestimated, William D. Chey, MD, co-director of the Michigan Bowel Control Program at the University of Michigan and Healio Gastroenterology Peer Perspective Board member, said in a press release. Trulance presents an exciting new treatment option for patients with chronic constipation. Its efficacy and safety profile, plus its negligible systemic absorption, are attractive attributes that make it a welcome addition to our treatment options.

The FDA approved Trulance (plecanatide, Synergy Pharmaceuticals) at a 3-mg dose, taken orally once a day with or without food. The drug works in the upper GI tract to mimic uroguanylin and improve regular bowel function.

Approval came after two randomized, double blind, placebo-controlled clinical trials in which efficacy was studied in more than 2,600 patients and safety in more than 2,700. Patients were diagnosed with chronic idiopathic constipation (CIC) due to producing less than three spontaneous bowel movements (SBM) per week in the previous 3 months.

The efficacy responder rate defined as at least three complete SBM in a given week and at least one CSBM over baseline in the same week for at least 9 weeks was greater in both studies compared with placebo (21% vs. 10% and 21% vs. 13%; both P < .005). Those treated with plecanatide showed improvement in stool frequency, stool consistency and straining.

The FDA and manufacturer noted diarrhea as the most common adverse reaction (5% vs. 1% in placebo). Due to the risk for dehydration and lack of safety and efficacy data, the FDA said plecanatide should not be used in pediatric patients aged younger than 6 years and avoided from age 6 to age 18.

No one medication works for all patients suffering from chronic gastrointestinal disorders, Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research, said in the FDA press release. With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.

Synergy Pharmaceuticals said the medication will be available for CIC patients in the U.S. this quarter. It is also being studied in IBS-C, according to the company. by Katrina Altersitz

Disclosures: Beitz is an employee of the FDA. Chey reports he is a consultant for Albreio, Allergan, Ardelyx, IM Health, Ironwood, Nestle, Prometheus, QOL Medical, Salix, Syn Biologic and Takeda, and has received grant or research support from Ironwood, Nestle, Perrigo and Prometheus.


http://www.healio.com/gastroenterology/motility/news/online/%7B7113d768-8a31-4238-b2bd-8b0a8af012cf%7D/fda-approves-new-treatment-for-chronic-constipation?utm_source=maestro&utm_medium=email&utm_campaign=gastroenterology%20news

--------------------
Heather is the Administrator of the IBS Message Boards. Shes the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!

Post Extras Print Post Remind Me! Notify Moderator

Entire thread
Subject Posted by Posted on
* Pharmaceutical HeatherAdministrator 07/14/03 01:50 PM
. * Long-term cannabis use increases risk for IBS HeatherAdministrator 10/19/17 04:04 PM
. * FDA approves new drug for chronic constipation HeatherAdministrator 01/26/17 03:05 PM
. * Mixed Opioid Agent Adds to Growing List of Therapies for IBS-D HeatherAdministrator 01/27/16 02:48 PM
. * Low-dose naltreoxone for the treatment of irritable bowel syndrome HeatherAdministrator 01/26/16 01:20 PM
. * Amitiza benefited patients with chronic idiopathic constipation HeatherAdministrator 02/10/15 04:15 PM
. * Medical Marijuana for Digestive Disorders: High Time to Prescribe? HeatherAdministrator 09/17/14 02:08 PM
. * Antibiotics Early in Life May Boost Obesity Risk HeatherAdministrator 08/18/14 03:13 PM
. * Antidepressants, psychological therapies effectively treated IBS HeatherAdministrator 07/15/14 02:49 PM
. * Proton pump inhibitor (acid reflux drugs) may cause heart disease HeatherAdministrator 09/23/13 03:22 PM
. * Older drugs are better than new ones HeatherAdministrator 06/13/13 02:00 PM
. * On Anti-Depressants? Some Raise Risk of C. Diff Infection HeatherAdministrator 05/13/13 05:51 PM
. * Heartburn drugs, NSAID painkillers use linked to IBS symptoms HeatherAdministrator 03/18/13 01:24 PM
. * FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation HeatherAdministrator 08/31/12 11:25 AM
. * 3-month FDA delay for potential IBS drug linaclotide HeatherAdministrator 04/23/12 01:45 PM
. * Latest FDA watch list includes GI drugs HeatherAdministrator 04/23/12 01:42 PM
. * Antibiotics that reduce gut bacteria linked to obesity HeatherAdministrator 05/06/11 12:25 PM
. * Rifaximin: a unique gastrointestinal-selective antibiotic for enteric diseases HeatherAdministrator 02/10/11 10:23 AM
. * Antacids increase risk of pneumonia HeatherAdministrator 01/14/11 04:35 PM
. * Editorial - Antibiotic Rifaximin (Xifaxan) Therapy for the Irritable Bowel Syndrome HeatherAdministrator 01/07/11 03:01 PM
. * Antiobiotic Rifaximin (Xifaxan) for Patients with Irritable Bowel Syndrome without Constipation HeatherAdministrator 01/07/11 02:59 PM
. * Proton Pump Inhibitor Drugs Tied to 80% Increase in Clostridium difficile Risk HeatherAdministrator 11/10/10 11:29 AM
. * Phase 3 clinical trials of linaclotide for IBS constipation HeatherAdministrator 10/13/10 02:44 PM
. * An over-the-counter drug for constipation offers superior symptom relief compared with a commonly used prescription agent HeatherAdministrator 07/16/10 03:17 PM
. * Benefit/risk ratio of Renzapride not sufficient to warrant further study in IBS-C HeatherAdministrator 04/07/10 01:32 PM
. * Adverse effects of drugs on small intestine and colon HeatherAdministrator 03/16/10 11:23 AM
. * Children's Belly Aches Don't Disappear With Antidepressant HeatherAdministrator 03/11/10 01:14 PM
. * Survey: Marijuana Use In Patients With IBS HeatherAdministrator 01/12/10 03:17 PM
. * FDA Approves Amitiza for IBS-C HeatherAdministrator 05/23/08 10:59 AM
. * Zelnorm no longer available except for emergency use HeatherAdministrator 04/11/08 12:05 PM
. * Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation. HeatherAdministrator 02/15/08 11:20 AM
. * Role of Antibiotics vs Conventional Pharmacotherapy in Treating Symptoms of Irritable Bowel Syndrome HeatherAdministrator 01/03/08 04:45 PM
. * FDA permits the restricted use of Zelnorm HeatherAdministrator 08/09/07 11:41 AM
. * Antidepressant Therapy (Imipramine and Citalopram) for Irritable Bowel Syndrome HeatherAdministrator 06/20/07 01:56 PM
. * Neuromuscular Dysfunction and IBS: Clinical Implications for Drug Use HeatherAdministrator 02/04/07 04:30 PM
. * Enteric Bacteria and IBS HeatherAdministrator 11/26/06 02:51 PM
. * Rifaximin vs Placebo in Reducing Symptoms in Adults With IBS HeatherAdministrator 11/26/06 02:39 PM
. * Antibiotic Rifaximin Appears Safe and Effective for Irritable Bowel Syndrome HeatherAdministrator 10/26/06 10:29 AM
. * Citalopram (Celexa) Improves Symptoms of Irritable Bowel Syndrome HeatherAdministrator 10/14/06 12:57 PM
. * Marijuana eases chronic pain HeatherAdministrator 07/17/06 11:49 AM
. * Doctors group launches war on drug ads HeatherAdministrator 07/17/06 11:17 AM
. * New IBS drug in development in Japan HeatherAdministrator 07/05/06 05:13 PM
. * Marijuana and the gastrointestinal tract HeatherAdministrator 06/12/06 03:38 PM
. * Zelnorm Rejected Again in Europe HeatherAdministrator 04/02/06 03:25 PM
. * Antidepressants for IBS HeatherAdministrator 03/16/06 12:31 PM
. * Takeda Laxative Wins U.S. Approval for Adults HeatherAdministrator 02/18/06 01:36 PM
. * Cilansetron: ; Solvay Pharmaceuticals suspends registration activites in the U.S., HeatherAdministrator 01/18/06 04:15 PM
. * Hearburn Drugs Cause Diarrhea HeatherAdministrator 01/08/06 05:10 PM
. * Zelnorm fails to win EU panel backing HeatherAdministrator 12/21/05 11:25 AM
. * Non-steroidal anti-inflammatory drugs and gastrointestinal damage HeatherAdministrator 12/08/05 12:51 PM
. * Octreotide May Be Effective in Treatment of Nonconstipated IBS HeatherAdministrator 12/08/05 12:31 PM
. * Lack of Lasting Effectiveness of Miralax Laxative Treatment of Constipation. HeatherAdministrator 08/07/05 04:18 PM
. * Acute Hepatitis Associated With Lotronex HeatherAdministrator 07/24/05 02:37 PM
. * FDA revisions to safety labeling for Lotronex (alosetron ) HeatherAdministrator 05/22/05 06:46 PM
. * Clinical pharmacology of new motility promoting agents HeatherAdministrator 05/22/05 06:33 PM
. * Rationale for Using Serotonergic Agents to Treat Irritable Bowel Syndrome HeatherAdministrator 05/08/05 06:21 PM
. * Zelnorm Associated With Rare Cases of Severe Diarrhea, Ischemic Colitis HeatherAdministrator 04/24/05 03:48 PM
. * Clinical Response to Tricyclic Antidepressants in Functional Bowel Disorders not Related to Dosage HeatherAdministrator 03/28/05 01:32 PM
. * Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS HeatherAdministrator 02/19/05 05:56 PM
. * Irritable Bowel Syndrome Medications Side Effects Survey HeatherAdministrator 11/09/04 02:04 PM
. * On the Relationship Between Colon Ischemia, Irritable Bowel Syndrome, and Serotonergic Therapy of Irritable Bowel Syndrome HeatherAdministrator 10/24/04 07:10 PM
. * New Risk Information on Zelnorm for IBS for Women HeatherAdministrator 07/11/04 02:18 PM
. * The Relationship among Previous Antimicrobial Use and H. Pylori Infections HeatherAdministrator 06/27/04 01:33 PM
. * Therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome HeatherAdministrator 06/04/04 03:54 PM
. * Pharmaceutical companies funding a number of studies into IBS in the UK HeatherAdministrator 05/25/04 12:00 PM
. * Irritable bowel syndrome helped by Paroxetine, a drug for depression HeatherAdministrator 05/10/04 02:15 PM
. * Fears cause low sales of Lotronex HeatherAdministrator 05/10/04 01:46 PM
. * Zelnorm Warning Issued by FDA HeatherAdministrator 05/10/04 01:01 PM
. * Renzapride Improves Symptoms in Constipation-Predominant Irritable Bowel Syndrome HeatherAdministrator 12/01/03 06:14 PM
. * Clinical Trial Guidelines for Pharmacological Treatment of IBS - Pharmacological Options HeatherAdministrator 12/01/03 05:55 PM
. * SOLVAY presses ahead with cilansetron, a new IBS drug HeatherAdministrator 11/18/03 03:43 PM
. * Measuring Treatment Effects in IBS Trials HeatherAdministrator 10/20/03 03:30 PM
. * FDA Orders Novartis To Pull Zelnorm Ads HeatherAdministrator 10/07/03 11:25 PM
. * Step-down dosage of PPI drugs for hearburn HeatherAdministrator 09/30/03 01:26 PM
. * Evaluation of drug treatment in irritable bowel syndrome HeatherAdministrator 09/30/03 12:52 PM
. * Pain Relievers and Intestinal Disorders HeatherAdministrator 09/16/03 04:20 PM
. * Hypersensitivity and hyperreactivity in IBS: opportunity for drug discovery HeatherAdministrator 07/18/03 12:39 PM
. * Antidepressants in the Treatment of IBS and Other Functional GI Disorders HeatherAdministrator 07/18/03 12:20 PM
. * Use of Antidepressants in the Treatment of IBS? HeatherAdministrator 07/14/03 03:58 PM
. * Combined use of SSRIs and NSAIDs increases the risk of GI adverse effects HeatherAdministrator 07/14/03 03:15 PM

Extra information
0 registered and 15 anonymous users are browsing this forum.

Moderator:  Heather 



Permissions
You cannot post until you login
You cannot reply until you login
HTML is enabled
UBBCode is enabled

Thread views: 348866

Jump to

| Privacy statement Help for IBS Home

*
UBB.threads™ 6.2


Shop For IBS Here!