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The CE medical device Enterosgel is an oral intestinal adsorbent gel, available OTC and indicated for the symptomatic treatment of acute and chronic IBS diarrhoea.
About
Enterosgel is a safe and effective OTC medical device licensed in the EU for oral administration in the symptomatic treatment of acute diarrhoea and diarrhoea-predominant irritable bowel syndrome (IBS-D). It is an organosilicon compound forming an intestinal adsorbent gel which is easy to ingest mixed in water. Several studies show its efficacy in reducing stool frequency and improving consistency in both acute and chronic diarrhoea.1-5 The mechanism of action leading to a reduction in diarrhoea from any cause, relates to Enterosgel’s ability to bind and remove large molecules from the gut which drive diarrhoea including; immune chemicals, bacterial toxins, viral particles, bile salts, and fat molecules.6-8 Other therapeutic options such as oral rehydration solution (ORS), do not reduce the duration of diarrhoea, and anti-diarrhoeal drugs such as loperamide are not recommended for use in children, long term and have safety issues. Enterosgel has a good safety profile for use in children, pregnant women and the elderly during its 30-year history; current worldwide sales exceed 5mln units per year with no adverse events reported and few side effects. It has been used safely in several hundred clinical trials, including an ongoing post market UK study of Enterosgel in the treatment of IBS-D in adults (ISRCTN17149988) which is showing promising results. Acute intestinal infections are common conditions causing high morbidity and mortality especially in the young and elderly, resulting in a significant burden on health service resources and the economy. In the UK there are 17 mln cases each year resulting in 1 mln GP consultations, with approximately 10% of children under 5 years presenting to healthcare services each year with this condition. The treatments recommended for acute diarrhoea by the National Institute for Health and Care Excellence guidance are fluid and nutritional management (ORS), with anti-diarrhoeal drugs considered unnecessary and only advisable for specified groups and not children under 12 years. Enterosgel shows a significant re duction in the duration of diarrhoea compared to standard care and offers a safe alternative option in vulnerable groups such as children (children 1–3 years on advice of a doctor), pregnant women and the elderly. A possible benefit of Enterosgel use is in reducing the level of complications of diarrhoea-related bacterial infection, which in 36% of cases can be followed by prolonged post-infective irritable bowel syndrome. This drug-free innovative treatment can open opportunities for reducing the number of prescriptions and use of opioid anti-diarrhoeal drugs especially for vulnerable groups of patients. Irritable bowel syndrome (IBS) is common worldwide, it has an estimated global prevalence is 11%. IBS occurs in 17% of the population in the UK, but prevalence is thought to be higher than this as many people with the disorder do not seek medical advice. Approximately one third of patients have IBS with diarrhoea (IBS-D). The underlying pathophysiology of IBS is complex, and the efficacy of medical treatment is variable. Due to the complex nature of IBS, there is no recognised standard treatment and currently no cure. All patients with IBS have symptoms of abdominal pain and disordered stool motions, and treatment often focuses on managing one symptom. The most common treatment for IBS-D is Loperamide, this is an opioid and slows gut motility, it does not treat the underlying cause of diarrhoea. It has safety issues, several serious side effects, many contraindications, is not for use in pregnancy and can only be used for 2 weeks for repeated attacks and for no longer than 48hours. Other options include Buscopan, an antispasmodic, which only relieves abdominal pain, cannot be used for longer than 2 weeks without the advice of a doctor, and cannot be used in children under 12 years. Enterosgel is a safe OTC option able to relieve both diarrhoea and abdominal pain, with few minor side effects or contraindications that can be taken during pregnancy and breast feeding and continuously for 21 days followed by a short break. The device is effective and removes substances associated with IBS symptoms, unlike other pharmaceutical options. It can be used long term and offers a flexible dosage option that can be tailored to individual patient’s needs; often patients take a lower maintenance dose and then increase the dose during flare-ups. References 1. Howell C.A., et al. Enterosgel® for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial. BMJ Open Gastroenterology 2019;6(1):e000287 2. Pavlov A.I., Fadina Zh V. Tactics of Management of diarrhoea of non-infectious genesis in hospital. Military Medical Journal. 2018;6:49-54 3. Tkachenko, E.I., et al. Efficiency and safety of Enterosgel (polymethylsiloxane polyhydrate) in the treatment of irritable bowel syndrome. Minerva Gastroenterologica e Dietologica, 205;61(Suppl. 1), N2: 1-5 4. Ruzhentsova, T.A., et al. Choice of an adequate therapy regimen for acute enteric infections in children: results of a randomized trial. Epidemiology and Infectious Diseases. 2016;№4: 70-74 (In Russian) 5. Usenko, D.V., et al. Application of enterosorbents in the treatment of intestinal infections in children with concomitant atopic dermatitis. Pharmateca 2015; N10: 31-35 (In Russian) 6. Howell CA, et al. Investigation of the adsorption capacity of the enterosorbent Enterosgel for a range of bacterial toxins, bile acids and pharmaceutical drugs. Scientific reports. 2019;9:5629 7. Nikolaev, V.G. Enterosgel. Bogdana Publ., Kiev, Ukraine, 2010, 140 pp. 8. Barbova AI. The sorption of human and animal rotaviruses by Enterosgel. Mikrobiol Z. 1995 Sep-Oct;57(5):52-7 (In Russian)
Key Benefits
Sales of OTC Gastrointestinal medicines in the UK reached almost £288 mln in 2018, with IBS the fastest growing category per year. Patients use a variety of prescription, OTC, and complementary therapies to treat their IBS. Each year, many patients with IBS receive a prescription for medication. However only a third of IBS patients report satisfaction with the therapies they currently use to treat their IBS symptoms, with less than half saying their prescription drugs are “effective”. Promoting the safe and effective drug free OTC treatment Enterosgel could provide a treatment option to this expanding IBS market. This option could be offered to patients seeking a complementary therapy and those dissatisfied with their prescription drugs and seeking alternatives. The diarrhoea category is the second largest for UK OTC Gastro-intestinal sales. The 90g Enterosgel children’s package recently developed and approved by BOOTS PML team will impact significantly on sales in the GI area, as it will target the significant and unmet children’s market. The children specific variant will fill the gap in the acute intestinal infection market in this age group that experience the greatest need due to high prevalence of the condition but lack treatment options available for children. The 90g children’s package provides enough doses for the recommended three days of treatment for acute diarrhoea. The other variants (sachets, 90g and 225 tubes) provide a range to treatment options for patients to choose for an acute diarrhoea episode. As NICE guidance considers anti-diarrhoeal drugs unnecessary and only advisable for specified groups, not children under 12 years and as more evidence of serious side effects from these drugs emerges. This is an opportunity to steer patients away from these drugs to offer a safer drug free option to treat acute diarrhoea and improve patient outcomes and help minimise antibiotic resistance.
Applications
Enterosgel is currently indicated for the symptomatic treatment of acute diarrhoea and chronic diarrhoea associated with IBS-D. The mechanism of action for both types are diarrhoea are thought to be similar. For acute diarrhoea the removal of bacterial toxins and viral particles, and with regards IBS may be the removal of bacterial breakdown products, immune proteins that are released by the body, together with fat molecules and bile acids - which altogether can contribute to the development of diarrhoea in these patients. The target market for both acute diarrhoea and IBS are significant. IBS is common worldwide, its estimated global prevalence is 11%, with more recent studies indicating an increasing prevalence in newly developed and developing economies as they become ‘westernised’. As the general public become more aware of IBS and its symptoms, this may have also contributed towards the increased number of cases being recorded. It is estimated that in the UK about 17% of the population can have IBS, its more prevalent in women 23% and about 11% among men. The impact on quality of life for patients with IBS is significant and far-reaching, and similar to other chronic conditions. The duration and severity of symptoms that people with IBS get can range from inconvenient to incapacitating and can prevent individuals from taking part in everyday activities. WHO and Unicef claim that there are approximately two billion cases of diarrhoeal disease every year worldwide, and in children under 5 years of age, 1.9 million die from diarrhoea each year, most often in developing countries. Annually, in the UK, there are 17 million cases and 1 million physician consultations attributed to acute infectious diarrhoea. In the United States it has been estimated that between 179-375 mln episodes of acute diarrhoea occur each year. Diarrhea is also responsible for 4% of hospitalizations in children and 5000 deaths due to foodborne illness yearly. Estimates suggest that in the US, diarrhoea costs approximately $6 billion every year in the form of medical bills and lost productivity.