All Boards >> Irritable Bowel Syndrome Research Library

View all threads Posts     Flat     Threaded

Cilansetron: ; Solvay Pharmaceuticals suspends registration activites in the U.S.,
      01/18/06 04:15 PM
HeatherAdministrator

Reged: 12/09/02
Posts: 7799
Loc: Seattle, WA

CILANSETRON; Solvay Pharmaceuticals suspends registration activites in the U.S., while discussions in Europe continue

Embargo : November 29, 2005 at 8:00 AM (Brussels time)

Solvay Pharmaceuticals announced today it has suspended regulatory activities for cilansetron with the United States regulatory agency, the Food and Drug Administration. Given the amount of clinical work requested and in the framework of the estimated potential market there, Solvay prefers to give priority to the development of other compounds in its research and development pipeline.

However, in the United Kingdom, the reference member state for Europe-wide registration, discussions on cilansetron with the Medicines and Healthcare products Regulatory Agency continue. Solvay expects to announce its decision for Europe during 2006.

Cilansetron, is a novel 5-HT3 receptor antagonist which decreases gastrointestinal motility, secretion, and sensation. Efficacy and safety studies have included more than 4,000 patients worldwide, both men and women, with diarrhea predominance (D-IBS). Both men and women recorded symptom improvements and improved quality of life.

D-IBS
On average, IBS affects more than 11% of the EU population, with total annual direct costs estimates of some £45 million in the UK alone. The common symptoms of D-IBS are diarrhea, abdominal pain/discomfort, and fecal urgency. IBS has a significant, negative impact on the quality of life for the many men and women who suffer from this condition, causing lost days of work and interfering as well with home-based, social and leisure activities.

SOLVAY PHARMACEUTICALS is a research driven group of pharmaceutical companies in Solvay that seeks to fulfil carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, pancreatic enzymes, gastroenterology and men's and women's health. Solvay Pharmaceuticals employs about 13,000 people worldwide after the acquisition of Fournier Pharma in July 2005.

SOLVAY is an international chemicals and pharmaceuticals group with headquarters in Brussels. It is present in more than 50 countries and employs some 33,000 people in its Chemicals, Plastics and Pharmaceuticals activities. Including Fournier Pharma, its 2004 sales amounted to EUR 8.5 billion. Solvay is listed on the Euronext 100 index of top European companies.

http://www.solvaypress.com/pressreleases/0,,36423-2-0,00.htm

--------------------
Heather is the Administrator of the IBS Message Boards. She is 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!

Print     Remind Me     Notify Moderator    

Entire thread
* Pharmaceutical
HeatherAdministrator
07/14/03 01:50 PM
* Medical Marijuana Significant for Migraines, Fibromyalgia, and IBS
HeatherAdministrator
02/16/21 01:21 PM
* Heartburn drugs that are proton pump inhibitors could trigger IBS and SIBO
HeatherAdministrator
12/07/20 01:28 PM
* For IBS Patients, Cannabis Linked to Fewer Rehospitalizations
HeatherAdministrator
05/05/20 02:14 PM
* Cannabis could help a person defecate
HeatherAdministrator
04/14/20 12:17 PM
* FDA OKs Reintroduction of Tegaserod (Zelnorm) for IBS-C in Women Under 65
HeatherAdministrator
04/04/19 02:45 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 19 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: 530045

Jump to

| Privacy statement Help for IBS Home

*
UBB.threads™ 6.2


HelpForIBS.com BBB Business Review