Abstract
Rifamycin SV MMX® (Aemcolo™; Relafalk™) is a novel oral formulation of the antibacterial rifamycin SV that uses MultiMatrix (MMX®) technology to enable colonic delivery. Specifically, the active ingredient (rifamycin SV) is released throughout the colon, where it acts locally in the intestinal lumen; systemic absorption is minimal. Rifamycin SV MMX® exhibits antibacterial activity against a broad spectrum of clinically relevant enteropathogens and is available in the EU and the USA for the treatment of adults with traveller’s diarrhoea. In two multinational, phase III studies, rifamycin SV MMX® (400 mg twice daily for 3 days) effectively shortened the duration of non-dysenteric traveller’s diarrhoea in adults, being significantly more effective than placebo and noninferior to ciprofloxacin in reducing median time to last unformed stool. As expected (given its poor systemic absorption), rifamycin SV MMX® was well tolerated in this patient population, with the overall incidence of treatment-emergent adverse events generally similar to those of placebo and ciprofloxacin. Current evidence indicates that twice-daily rifamycin SV MMX® is an effective and well tolerated treatment option for shortening the duration of non-dysenteric traveller’s diarrhoea in adults.
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20 June 2019
A Correction to this paper has been published: https://doi.org/10.1007/s40261-019-00819-z
References
Steffen R, Hill DR, DuPont HL. Traveler’s diarrhea: a clinical review. JAMA. 2015;313(1):71–80.
BMJ Best Practice. Traveler’s diarrhea. 2018. https://bestpractice.bmj.com/topics/en-us/601. Accessed 13 May 2019.
DuPont HL. Systematic review: the epidemiology and clinical features of travellers’ diarrhoea. Aliment Pharmacol Ther. 2009;30(3):187–96.
Riddle MS, Connor BA, Beeching NJ, et al. Guidelines for the prevention and treatment of travelers’ diarrhea: a graded expert panel report. J Travel Med. 2017;24(Suppl 1):S57–74.
Riddle MS, Connor BA, Tribble DR. Targeted therapy in travelers’ diarrhea: what is the role for the non-absorbable? J Travel Med. 2014;21(6):365–8.
Cosmo Pharmaceuticals. Cosmo announces its licensee Dr. Falk Pharma received approval in the European Decentralized Procedure for Relafalk (Rifamycin SV MMX) in travelers’ diarrhea. 2018. http://www.cosmopharma.com/. Accessed 13 May 2019.
Di Stefano AF, Rusca A, Loprete L, et al. Systemic absorption of rifamycin SV MMX administered as modified-release tablets in healthy volunteers. Antimicrob Agents Chemother. 2011;55(5):2122–8.
US FDA Center for Drug Evaluation and Research. Multi-discipline review. 2018. http://www.fda.gov/. Accessed 13 May 2019.
Farrell DJ, Putnam SD, Biedenbach DJ, et al. In vitro activity and single-step mutational analysis of rifamycin SV tested against enteropathogens associated with traveler’s diarrhea and Clostridium difficile. Antimicrob Agents Chemother. 2011;55(3):992–6.
Cosmo Pharmaceuticals. Aemcolo (Rifamycin SV MMX®): US prescribing information. 2018. http://www.fda.gov/. Accessed 13 May 2019.
Dr Falk Pharma GmbH. Relafalk (rifamycin SV MMX®) 200 mg modified-release tablets: EU summary of product characteristics 2018. https://www.gov.uk/pil-spc. Accessed 16 May 2019.
Nardelli S, Pisani LF, Tontini GE, et al. MMX® technology and its applications in gastrointestinal diseases. Ther Adv Gastroenterol. 2017;10(7):545–52.
DuPont HL, Petersen A, Zhao J, et al. Targeting of rifamycin SV to the colon for treatment of travelers’ diarrhea: a randomized, double-blind, placebo-controlled phase 3 study. J Travel Med. 2014;21(6):369–76.
Steffen R, Jiang ZD, Gracias Garcia ML, et al. Rifamycin SV-MMX® for treatment of travelers’ diarrhea: equally effective as ciprofloxacin and not associated with the acquisition of multi-drug resistant bacteria. J Travel Med. 2018. https://doi.org/10.1093/jtm/tay116.
Ericsson CD, DuPont HL, Mathewson JJ, et al. Test-of-cure stool cultures for traveler’s diarrhea. J Clin Microbiol. 1988;26(5):1047–9.
Woerther PL, Andremont A, Kantele A. Travel-acquired ESBL-producing Enterobacteriaceae: impact of colonization at individual and community level. J Travel Med. 2017;24(Suppl 1):S29–34.
Acknowledgements
During the peer review process, the manufacturer of rifamycin SV MMX® was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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Sheridan Hoy is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
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The manuscript was reviewed by: H. Bhally, Waitemata District Health Board, Auckland, New Zealand; B. A. Connor, Weill Cornell Medical College and The New York Center for Travel and Tropical Medicine, New York, NY, USA.
The original version of this article was revised: Modifications have been made in Sect. 5 “Tolerability of Rifamycin SV MMX®”, the first sentence of the second paragraph.
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Hoy, S.M. Rifamycin SV MMX®: A Review in the Treatment of Traveller’s Diarrhoea. Clin Drug Investig 39, 691–697 (2019). https://doi.org/10.1007/s40261-019-00808-2
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DOI: https://doi.org/10.1007/s40261-019-00808-2