dm+d

Unassigned

New Medicines

Relafalk (EU), Aemcolo (US) Traveller's diarrhoea

Information

Relafalk (EU), Aemcolo (US)
New formulation
Dr Falk
Aries Pharmaceuticals

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Mar 21Dr Falk has no plans to market this product in the UK in the near future [13].
Jul 20The Italian Agenzia del Farmaco grants Marketing Authorisation for Rifamycin SV MMX for traveller ´s diarrhoea [12].
Sep 19In the EU, Relafalk is licensed for treatment of travellers’ diarrhoea caused by non-invasive strains of Escherichia coli in adults [10].
Jul 19Aries Pharmaceuticals intends to launch in the US in Jul 19 [11].
Nov 18Cosmo Pharmaceuticals announces that its licensee Dr. Falk Pharma has received approval in the European Decentralized Procedure (DCP) for Relafalk (Rifamycin SV MMX) for treatment of travelers ´ diarrhoea. The DCP concerned the following Member States - Germany, United Kingdom, Spain, Denmark, Greece, Finland, Hungary, Norway, Portugal, Poland, Sweden and Bulgaria [10].
Nov 18Approved in US by the FDA - full indication is "for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults".[9].
Aug 18Currently pre-registration in US [8].
Aug 18Currently pre-registration in EU. Has been filed using the decentralised procedure [8].
Mar 18Filed in EU for traveller´s diarrhoea.[8]
Feb 18Cosmo website still indicates new drug applications in US and Europe are being prepared [6].
Oct 17Aemcolo granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US FDA for travellers’ diarrhoea [7].
Nov 16Cosmo website indicates new drug applications in US and Europe are being prepared [5].
Jan 16Cosmo website indicates that rifamycin SV MMX has not yet been filed in the US and EU studies continuing [4].
Mar 15Cosmo website indicates that rifamycin SV MMX will be filed in the US within a few months of Oct 2014, but development in the EU is still the PIII stage [3].
Feb 14Currently PIII in the EU [2].

Category

Antibiotic. Cosmo Multi Matrix (MMX) technology is used in the product so that rifamycin is delivered directly to the lumen of the colon, thereby avoiding unwanted effects on the bacterial flora living in the upper portions of the GI tract.
Travelers’ diarrhoea is primarily caused by the ingestion of food or water contaminated by pathogenic strains of bacteria. Each each year between 20% and 50% of international travelers develop diarrhoea, primarily caused by bacteria. [1]
Traveller's diarrhoea
Oral

Trial or other data

Nov 16Cosmo announce positive results from two pivotal trials. Clinical Cure Rate of rifamycin SV MMX vs ciprofloxacin was 85.0% vs. 84.8% respectively (HR≤0.764; p=0.0018), in the non-inferiority Rifamycin SV-MMX Vs Ciprofloxacin in Acute Traveller´s Diarrhoea (ERASE) (NCT01208922) trial. NCT01142089 showed superiority of rifamycin SV MMX vs placebo (p=0.0008) [5].
Sep 12Phase III randomised, double-blind, placebo-controlled study (NCT01142089) (n=264: 65 placebo and 199 rifamycin SV MMX). Dosing regimen: 400mg (2x200mg) tablets twice daily for 3 days. Primary endpoint was Time to Last Unformed Stool (TLUS), defined as time between administration of first dose and time that the last unformed stool was passed. In the ITT population (n=264) the TLUS was 46 hours for rifamycin SV MMX and 68 hrs for placebo, p=0.0008. Results in the PP population (n=240) were similar to those in the ITT population. Most frequent treatment-emergent adverse events experienced by at least 2% of patients were headache (8.0% rifamycin SV MMX vs. 9.2% placebo), diarrhoea (5.0% vs. 9.2%), infectious diarrhoea (5.0% vs. 7.7%), constipation (3.5% vs. 1.5%), amoebic dysentery (0% vs. 3.1%) and GI infection (0% vs. 3.1%). [1]
Sep 12Rifamycin SV MMX utilises proprietary MMX colonic delivery technology, which consists of a sequence of lipophilic and amphiphilic matrices dispersed within a hydrophilic matrix. MMX tablets are coated with gastro-resistant polymers that protect the rifamycin against degradation in the upper gastrointestinal tract and delay the release of it until the tablet reaches the colon. Rifamycin SV MMX is covered by two issued U.S. patents that expire in 2020 and 2025. [1]