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It is only for medical professionals to read and refer to "New Digestion Medicine is Coming", the progress of new digestion medicine is here! Irritable bowel syndrome (IBS) is a type of bowel dysfunction syndrome.
The typical symptoms are abdominal pain, bloating, or abdominal discomfort associated with abnormal bowel movements.
The pathogenesis of IBS is more complicated.
Factors such as mentality, diet, and cold can induce recurring or aggravating symptoms.
Patients with IBS often bear huge mental and physical burdens, and at the same time they also increase their financial burdens due to frequent medical treatment.
The treatment of diarrhea and constipation in IBS is considered to be one of the main challenges facing the world in the past decade.
Drugs currently approved for the treatment of IBS include antibiotic drugs (rifaximin, etc.
), opioid receptor agonist/antagonist drugs, selective serotonin (5-HT3) antagonists, and some intestinal flora regulation Drugs, but their safety, effectiveness, and price issues restrict the use of these drugs.
Faced with this global challenge, major pharmaceutical companies have joined in, committed to developing safe, effective and cheaper drugs, and aiming at new disease treatment mechanisms to promote a new revolution in the treatment of IBS.
In this issue, we will take stock of 4 new drugs that have received widespread attention in the field of IBS treatment in recent years.
Linaclotide Company: AstraZeneca (UK) Indication: Adult constipated irritable bowel syndrome (IBS-C) (domestic listing) Linaclotide is a guanylate cyclase-C Receptor agonist, after it binds to intestinal guanylate cyclase-C, it increases the concentration of intracellular and extracellular cyclic guanosine phosphate (cGMP).
The increase of intracellular cGMP concentration can stimulate the secretion of intestinal juice and accelerate the stomach Intestinal peristalsis, thereby increasing the frequency of bowel movements; increased extracellular cGMP concentration can reduce pain nerve signal transmission and relieve symptoms of abdominal pain.
Through this dual mechanism of action, Linaclotide simultaneously solves the two major problems of defecation and relief of abdominal pain/bloating.
The effective and safe dose of linaclotide is 290ug/day, which has shown good effect and tolerability in phase III clinical trials [1].
Linaclotide is the world's first guanylate cyclase-C receptor agonist drug.
It was approved by the U.
S.
Food and Drug Administration (FDA) on August 30, 2012 for the treatment of constipation-type bowel disease.
Irritable syndrome (IBS-C) and chronic idiopathic constipation.
Linaclotide was approved by the National Medical Products Administration (NMPA) of my country for the treatment of IBS-C in adults in China on January 15, 2019, filling the gap in the treatment of IBS-C in China.
Recently, Linaclotide has been included in the 2020 version of the drug catalog.
Through medical insurance reimbursement, patients with IBS-C can enjoy high-quality innovative drugs at low prices.
Peppermint oil (PO) Company: Nature's Way (United States) Indication: Relief of symptoms such as abdominal pain and bloating in IBS patients over 8 years old (marketed in Europe and America) Peppermint oil is a natural extract drug that antagonizes calcium channels and 5 -HT3 receptor, which activates κ-opioid receptor, relieves the discomfort symptoms such as abdominal pain and bloating in patients with IBS.
The results of a randomized double-blind clinical trial show that the intestinal sustained-release preparation of peppermint oil is better than placebo in improving abdominal pain, abdominal discomfort and the severity of IBS.
In addition, its side effects are relatively mild, mainly including headache, dizziness, anal burning, nausea, dry mouth, increased appetite, belching, indigestion and heartburn [2].
At present, the European Medicines Agency (EMA) has approved the marketing of peppermint oil preparations, which are used to relieve symptoms such as abdominal pain and bloating in IBS patients over 8 years old.
The recommended dose is 0.
2-0.
4ml (2-3 times a day).
In the United States, peppermint oil enteric-coated capsules developed by companies such as Nature's Way have been on the market, and the current market response is good.
Tenapanor (Tenapanor) Company: Ardelyx (USA) Indication: Adult IBS-C (listed in the US) Tenapanor is a new selective inhibitor sodium hydrogen exchanger 3 (NHE3) inhibitor, which can Reduce the absorption of sodium by the colonic epithelium, which leads to an increase in the secretion of water into the intestinal cavity, accelerates the transit time of the intestine, and causes the stool to become soft.
The recommended oral dose of Tenapano is 50 mg twice a day, but it is contraindicated in children [3].
On December 11, 2017, Shanghai Fosun Pharmaceutical Company and Ardelyx Company signed an agreement to approve Tenapano to be sold in Mainland China, Hong Kong and Macau for the treatment and prevention of IBS-C.
On September 12, 2019, Tenapano was approved by the FDA for listing in the United States, with the indication for adult IBS-C.
Vibegron: Urovant Sciences (United States) Indication: Relief of abdominal pain symptoms of IBS (Phase II clinical trial) Vibegron is a new, effective and highly selective β3-adrenergic receptor Agonist with long half-life (25-38 hours).
Vibergron was approved by the US FDA in 2020 for the treatment of overactive bladder.
There is currently no IBS analgesic on the market, and Vibergron has shown potential pain relief effects in previous studies.
Therefore, Urovant Sciences promoted the clinical study of Vibegron for pain relief in IBS patients, and announced the top-line data of the phase IIa randomized double-blind placebo-controlled trial of Vibegron in the clinical phase IIa of Vibegron at the end of 2020, which evaluated Vibegron.
Geron 70mg dose) treatment of female IBS accompanied by diarrhea and abdominal pain.
Unfortunately, the results show that the treatment effect of the medication group has no advantage over the placebo group [4].
Although the results of the Phase II clinical trial did not achieve the expected results, Urovant Sciences did not give up.
A new round of long-term large-sample clinical research is underway, and this column will continue to pay attention to its progress. Conclusion: In addition to the above-mentioned drugs that have received widespread attention, there are also a number of new drugs that are undergoing early clinical trials (such as Olorinab, AST-120 and Enterosgel, etc.
) or are approved for regional use (such as the STW approved for marketing in Germany) -5).
In addition, the improvement of the mental symptoms and social burden of IBS patients is also a problem that cannot be ignored by clinicians and researchers, which involves the establishment of a comprehensive management model for IBS diseases.
For IBS-related depressive symptoms, citalopram, fluvoxamine, paroxetine, etc.
are recommended for selective use in such patients, but the long-term safety and efficacy still need more research evidence to support.
In general, there is no guideline specific treatment method for IBS so far, and more than 60% of patients still have poor feedback on existing therapies in clinical practice.
Therefore, we still have a long way to go in the field of IBS specific drug development and integrated disease management.
Reference: [1]Nee JW,Johnston JM,Shea EP,et al.
Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation:pooled Phase 3 analysis.
Expert Rev Gastroenterol Hepatol.
2019 Apr; 13(4):397-406.
[2]Zsa RMWeerts.
Et al.
Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.
Gastroenterology.
2019.
[3]Markham A.
Tenapanor :First Approval.
Drugs.
2019 Nov;79(17):1897-1903.
doi:10.
1007/s40265-019-01215-9.
PMID:31677150.
[4]Urovant Sciences Announces Topline Data from Phase 2a Study of Vibegron.
https ://www.
businesswire.
com/news/home/20201124005971/en/ (The above drugs are listed in no particular order, listed in alphabetical order, for medical professionals to read only) Scan the code to download the doctor station App5w+ drugs for free query This article source: medical digestion liver disease channel author: Liu Han Yang paper review: Deputy Director Yang Weisheng Jingdezhen City second people's hospital physician editor: Mary original copyright notice for reprint this article, please contact your authorized - End - posting / reprint / business cooperation , Please contact: xh@yxj.
org.
cn
The typical symptoms are abdominal pain, bloating, or abdominal discomfort associated with abnormal bowel movements.
The pathogenesis of IBS is more complicated.
Factors such as mentality, diet, and cold can induce recurring or aggravating symptoms.
Patients with IBS often bear huge mental and physical burdens, and at the same time they also increase their financial burdens due to frequent medical treatment.
The treatment of diarrhea and constipation in IBS is considered to be one of the main challenges facing the world in the past decade.
Drugs currently approved for the treatment of IBS include antibiotic drugs (rifaximin, etc.
), opioid receptor agonist/antagonist drugs, selective serotonin (5-HT3) antagonists, and some intestinal flora regulation Drugs, but their safety, effectiveness, and price issues restrict the use of these drugs.
Faced with this global challenge, major pharmaceutical companies have joined in, committed to developing safe, effective and cheaper drugs, and aiming at new disease treatment mechanisms to promote a new revolution in the treatment of IBS.
In this issue, we will take stock of 4 new drugs that have received widespread attention in the field of IBS treatment in recent years.
Linaclotide Company: AstraZeneca (UK) Indication: Adult constipated irritable bowel syndrome (IBS-C) (domestic listing) Linaclotide is a guanylate cyclase-C Receptor agonist, after it binds to intestinal guanylate cyclase-C, it increases the concentration of intracellular and extracellular cyclic guanosine phosphate (cGMP).
The increase of intracellular cGMP concentration can stimulate the secretion of intestinal juice and accelerate the stomach Intestinal peristalsis, thereby increasing the frequency of bowel movements; increased extracellular cGMP concentration can reduce pain nerve signal transmission and relieve symptoms of abdominal pain.
Through this dual mechanism of action, Linaclotide simultaneously solves the two major problems of defecation and relief of abdominal pain/bloating.
The effective and safe dose of linaclotide is 290ug/day, which has shown good effect and tolerability in phase III clinical trials [1].
Linaclotide is the world's first guanylate cyclase-C receptor agonist drug.
It was approved by the U.
S.
Food and Drug Administration (FDA) on August 30, 2012 for the treatment of constipation-type bowel disease.
Irritable syndrome (IBS-C) and chronic idiopathic constipation.
Linaclotide was approved by the National Medical Products Administration (NMPA) of my country for the treatment of IBS-C in adults in China on January 15, 2019, filling the gap in the treatment of IBS-C in China.
Recently, Linaclotide has been included in the 2020 version of the drug catalog.
Through medical insurance reimbursement, patients with IBS-C can enjoy high-quality innovative drugs at low prices.
Peppermint oil (PO) Company: Nature's Way (United States) Indication: Relief of symptoms such as abdominal pain and bloating in IBS patients over 8 years old (marketed in Europe and America) Peppermint oil is a natural extract drug that antagonizes calcium channels and 5 -HT3 receptor, which activates κ-opioid receptor, relieves the discomfort symptoms such as abdominal pain and bloating in patients with IBS.
The results of a randomized double-blind clinical trial show that the intestinal sustained-release preparation of peppermint oil is better than placebo in improving abdominal pain, abdominal discomfort and the severity of IBS.
In addition, its side effects are relatively mild, mainly including headache, dizziness, anal burning, nausea, dry mouth, increased appetite, belching, indigestion and heartburn [2].
At present, the European Medicines Agency (EMA) has approved the marketing of peppermint oil preparations, which are used to relieve symptoms such as abdominal pain and bloating in IBS patients over 8 years old.
The recommended dose is 0.
2-0.
4ml (2-3 times a day).
In the United States, peppermint oil enteric-coated capsules developed by companies such as Nature's Way have been on the market, and the current market response is good.
Tenapanor (Tenapanor) Company: Ardelyx (USA) Indication: Adult IBS-C (listed in the US) Tenapanor is a new selective inhibitor sodium hydrogen exchanger 3 (NHE3) inhibitor, which can Reduce the absorption of sodium by the colonic epithelium, which leads to an increase in the secretion of water into the intestinal cavity, accelerates the transit time of the intestine, and causes the stool to become soft.
The recommended oral dose of Tenapano is 50 mg twice a day, but it is contraindicated in children [3].
On December 11, 2017, Shanghai Fosun Pharmaceutical Company and Ardelyx Company signed an agreement to approve Tenapano to be sold in Mainland China, Hong Kong and Macau for the treatment and prevention of IBS-C.
On September 12, 2019, Tenapano was approved by the FDA for listing in the United States, with the indication for adult IBS-C.
Vibegron: Urovant Sciences (United States) Indication: Relief of abdominal pain symptoms of IBS (Phase II clinical trial) Vibegron is a new, effective and highly selective β3-adrenergic receptor Agonist with long half-life (25-38 hours).
Vibergron was approved by the US FDA in 2020 for the treatment of overactive bladder.
There is currently no IBS analgesic on the market, and Vibergron has shown potential pain relief effects in previous studies.
Therefore, Urovant Sciences promoted the clinical study of Vibegron for pain relief in IBS patients, and announced the top-line data of the phase IIa randomized double-blind placebo-controlled trial of Vibegron in the clinical phase IIa of Vibegron at the end of 2020, which evaluated Vibegron.
Geron 70mg dose) treatment of female IBS accompanied by diarrhea and abdominal pain.
Unfortunately, the results show that the treatment effect of the medication group has no advantage over the placebo group [4].
Although the results of the Phase II clinical trial did not achieve the expected results, Urovant Sciences did not give up.
A new round of long-term large-sample clinical research is underway, and this column will continue to pay attention to its progress. Conclusion: In addition to the above-mentioned drugs that have received widespread attention, there are also a number of new drugs that are undergoing early clinical trials (such as Olorinab, AST-120 and Enterosgel, etc.
) or are approved for regional use (such as the STW approved for marketing in Germany) -5).
In addition, the improvement of the mental symptoms and social burden of IBS patients is also a problem that cannot be ignored by clinicians and researchers, which involves the establishment of a comprehensive management model for IBS diseases.
For IBS-related depressive symptoms, citalopram, fluvoxamine, paroxetine, etc.
are recommended for selective use in such patients, but the long-term safety and efficacy still need more research evidence to support.
In general, there is no guideline specific treatment method for IBS so far, and more than 60% of patients still have poor feedback on existing therapies in clinical practice.
Therefore, we still have a long way to go in the field of IBS specific drug development and integrated disease management.
Reference: [1]Nee JW,Johnston JM,Shea EP,et al.
Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation:pooled Phase 3 analysis.
Expert Rev Gastroenterol Hepatol.
2019 Apr; 13(4):397-406.
[2]Zsa RMWeerts.
Et al.
Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.
Gastroenterology.
2019.
[3]Markham A.
Tenapanor :First Approval.
Drugs.
2019 Nov;79(17):1897-1903.
doi:10.
1007/s40265-019-01215-9.
PMID:31677150.
[4]Urovant Sciences Announces Topline Data from Phase 2a Study of Vibegron.
https ://www.
businesswire.
com/news/home/20201124005971/en/ (The above drugs are listed in no particular order, listed in alphabetical order, for medical professionals to read only) Scan the code to download the doctor station App5w+ drugs for free query This article source: medical digestion liver disease channel author: Liu Han Yang paper review: Deputy Director Yang Weisheng Jingdezhen City second people's hospital physician editor: Mary original copyright notice for reprint this article, please contact your authorized - End - posting / reprint / business cooperation , Please contact: xh@yxj.
org.
cn
