ZINPLAVA (bezlotoxumab) is now available for prescription.
Ordering information is available on the brand website:
What is Zinplava™ ?
ZINPLAVA™ is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.
ZINPLAVA is not indicated for the treatment of CDI.
ZINPLAVA is not an antibacterial drug.
ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.
Full prescribing information can be read at
The Merck Access Program can help answer physician’s questions about:
Insurance coverage for patients
Prior Authorizations and Appeals
Coding and Billing
Potential financial assistance options for eligible patients
Full program details can be found at:
Also, Information about co-pay assistance for eligible, privately insured patients
Information about available independent assistance foundation support.
*PLEASE NOTE – The C Diff Foundation does not endorse any product, medication, and/or clinical study in progress and available. All website postings are strictly for informational purposes only.
Dificid (fidaxomicin) Product Access and Support Information:
AccessDIFICID is a support program for patients who have been prescribed DIFICID® (fidaxomicin) tablets.
Case managers are available M-F, 8 am – 8 pm; SAT, 9 am – 1 pm, ET, to provide the following information and support:
- Research your insurance benefits
- Obtain information about your out-of-pocket costs
- Provide information on co-pay assistance options
- Provide a referral to the Patient Assistance Program (PAP)
- Provide information about local pharmacies that stock DIFICID and/or options for overnight deliveries of DIFICID, where available, to the location of your choice
- Answer questions about filling out the AccessDIFICID Enrollment Form
Getting started is simple
- Download and complete the appropriate sections of the AccessDIFICID Enrollment Form with your health care provider
- You or your health care provider can fax the completed form to 1-888-997-9329
- A program representative will then contact you and your health care provider’s office
For continued information for AccessDIFICID please click on the following link:
*The C Diff Foundation does not endorse this or any medical and non-medical treatment available for the
treatment of a C. difficile infection. All possible treatment options are strictly information
based and for the general public and for general knowledge. Discuss all treatment options
with the physician/s providing care for and and all diagnosis. *
Rebiotix Receives Breakthrough Therapy Designation for RBX2660 – A Microbiota Restoration Therapy (MRT) for the Treatment of Recurrent Clostridium difficile Infection
Milestone reinforces Rebiotix as a leader in microbiota-based drug development and product commercialization
Rebiotix Inc. announced that U.S. Food and Drug Administration (FDA) has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection, a challenging to treat gastrointestinal (GI) infection that causes 29,000 deaths in the U.S. annually.
Rebiotix is a clinical stage biotechnology company that was founded to revolutionize the treatment of debilitating GI diseases by harnessing the power of the human microbiome. MRT is the Rebiotix drug platform for delivering healthy, live, human-derived microbes into a sick patient’s intestinal tract to treat disease.
Studies have shown that most cases of C diff infection occur after the normal microorganisms that reside in the gut have been disrupted by antibiotic use. Restoring the balance of microbes is thought to be key to breaking the cycle of recurrence. Lead Rebiotix product, RBX2660, is targeted at treating recurrent C diff.
“The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative,” said Rebiotix CEO Lee Jones. “The Breakthrough Therapy Designation marks the third regulatory milestone for our lead product, RBX2660, in the past two years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C diff.”
About the Breakthrough Therapy Designation
According to the FDA, Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). For more information please visit http://www.fda.gov/forpatients/approvals/fast/ucm405397.htm.
For additional Information click on the following link:
*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.
Over 1,450 patients were included in the analysis conducted in seven UK hospitals that introduced fidaxomicin, a narrow-spectrum antibiotic for the treatment of CDI, between July 2012 and July 2013. Data collected from 177 patients treated first-line with fidaxomicin during the 12-month evaluation period were compared with those from a retrospective cohort treated with broad-spectrum antibiotics – vancomycin and metronidazole – during the previous 12-month period.
In the two centres (A and B) where fidaxomicin was adopted as a first-line treatment for all patients diagnosed with CDI, a significant reduction in 28-day all-cause mortality was observed, from 18.2% to 3.1% (P<0.001) and 17.3% to 6.3% (P<0.05) respectively., The real-world analysis also supports clinical trial data in highlighting dramatically reduced recurrence rates: from 12.1% and 23.5% with vancomycin and metronidazole, to 3.1% in both centres with first-line fidaxomicin. For every 50 patients treated, this would result in 5 and 10 recurrences avoided in the two centres respectively.
A separate study recently looked at the impact of CDI treatment on environmental contamination. The analyses showed those treated with fidaxomicin are more than 20% less likely to contaminate their environment with CDI (36.8%) compared to patients treated with metronidazole and/or vancomycin (57.6%). This significant decrease in environmental contamination may further contribute to a reduction in secondary cases of CDI.
“The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified recurrence as the next big challenge to be met in the treatment of CDI, since it occurs in up to 25% of patients treated with current broad-spectrum therapies,” comments Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. “Fidaxomicin has limited activity against the ‘good bacteria’ in the gut and so can be considered to be a targeted treatment option. Preservation of the gut microflora likely contributes to the lower rates of recurrence seen after fidaxomicin treatment of CDI compared with those associated with broader-spectrum antibiotics like vancomycin.”
A CDI recurrence has been previously estimated to add an additional £20,249 on top of an estimated £13,146 spent to treat the initial infection due to prolonged hospital stay, ICU stay, high cost drugs and the surgery necessary to tackle it. An in-depth costing analysis at the two centres that adopted fidaxomicin as a first-line treatment revealed that in centre A the 5 recurrences that could be avoided for every 50 patients treated with the narrow-spectrum antibiotic would result in a cost saving of £19,490, and in centre B, for the 10 recurrences avoided, a cost saving of £121,144. With nearly 125,000 cases of CDI occurring in Europe each year, the potential cost saving for the treatment of this potentially fatal condition is likely to be far greater.
The cost-effectiveness of fidaxomicin has been reinforced in a recent study in France, with fidaxomicin proving to be both clinically and cost-effective compared to vancomycin. The main driver of cost-effectiveness was a significant reduction in the rate of recurrence, resulting in a reduced cost of hospitalisation. In the base case, fidaxomicin was cost-effective compared to vancomycin for all patients at a cost per QALY of €24,242. The cost per recurrence avoided was €1,877 and cost per faecal transplant avoided was €8,967.
In Europe the incidence and severity of CDI is increasing, posing a major threat to healthcare systems and patients.,,, Information suggests that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients. This suggests that CDI contributes to the death of around 27,000 people each year across Europe, around five times that of MRSA associated deaths.
ESCMID guidelines currently recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI.
NOTES TO EDITORS
About the CDI Service Evaluation study
The CDI Service Evaluation Project is the first and only real-world multicenter study assessing the effectiveness of current CDI treatment for UK patients in NHS Secondary Care Trusts in England. This evaluation looked specifically at the cost-effectiveness of fidaxomicin in clinical practice versus standard of care treatments (vancomycin and metronidazole) in seven trial centres from across the UK:
• Leeds Teaching Hospitals NHS Trust
• Guy’s and St Thomas’ NHS Foundation Trust
• County Durham & Darlington NHS Foundation Trust
• University Hospitals of Morecambe Bay – NHS Foundation Trust
• St George’s Healthcare NHS Trust
• University Hospitals of Leicester NHS Trust
• Derby Hospitals NHS Foundation Trust
The study was sponsored by Astellas Pharma Ltd.
About Clostridium difficile Infection
CDI is a recurring and preventable illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death. Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish. CDI is highly infectious and has surpassed MRSA as a leading cause of healthcare-acquired infection. It is most common in those taking broad-spectrum antibiotics that result in the disruption of normal bowel flora, and threatens those most vulnerable, including the elderly, patients who are immunocompromised or with renal impairment and those who have prolonged periods of hospitalisation., People in hospital with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI., Information suggests nearly 125,000 cases of CDI occur in Europe each year, and that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients. Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.,, The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.
About DIFICLIR (fidaxomicin)
DIFICLIR (fidaxomicin) is a first-in-class macrocyclic antibiotic targeted to kill the C. difficile bacteria while sparing the ‘good’ gut bacteria,,, and represents the newest development in CDI for over 20 years., In the largest Phase III trials in this area fidaxomicin was shown to be non-inferior in initial cure and clearly superior to current standard of care treatment – vancomycin – in achieving sustained clinical cure and addressing recurrence., ESCMID guidelines recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI. The safety profile of DIFICLIR is based on data from 564 patients with CDI treated with fidaxomicin in Phase III studies.
About Astellas Pharma EMEA
Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation’s focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.
FOR FULL ARTICLE:
As guests, Ms. Lee Jones, CEO Rebiotix, Inc. and Glenn Taylor, Microbiologist at Taymount Clinic discuss
Fecal Microbiota Transplant (FMT) AKA Microbiota Restoration Therapy, Research to Clinical
Ms. Lee Jones, Founder, President and CEO of Rebiotix Inc, has over thirty years of experience in the medical technology industry in large and small companies and academia. Rebiotix is developing a new category of biologic drugs that use live human-derived organisms to treat disease. Lead candidate RBX2660 (microbiota suspension) is currently undergoing clinical study for recurrent C. diff. infection.
Mr. Glenn Taylor is the Microbiologist at the Taymount Clinic just outside London in the UK. He has spent five years researching the commensal colonization of bacteria in the human digestive system. Listen in as both guests discuss the Fecal or Faecal Microbiota Transplant (FMT),also known as Microbiota Restoration Therapy to treat recurrent C. diff. infections and more – Research to Clinical.
Each “C. diff. Spores and More” episode becomes a pod-cast and can be easily accessed through our website:
“C. diff. Spores and More” spotlights world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more.
Through their interviews, the CDF mission will connect, educate, and empower many in over 180 countries.
Questions received through the show page portal will be reviewed and addressed by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP, Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago. Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.
Please join us Tuesdays in listening to the educational episodes of “C. diff. Spores and More”
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24 November 2014
Rebiotix has initiated our second clinical trial (PUNCH CD 2) focusing on the treatment of recurrent C. difficile infection!
The PUNCH CD 2 study is a Phase 2B randomized controlled trial to assess the effectiveness and safety of RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile (C. diff.) infection.
About the Study The PUNCH CD 2 study is the first multicenter prospective, multicenter, randomized, placebo-controlled, double-blind study of a microbiota restoration therapy. It has been designed to provide the highest quality of evidence to-date about this non-antibiotic approach to treating recurrent C. diff. infection.
Approximately 117 patients at over 20 sites in the US and Canada are expected to be enrolled in study.
Patients will be randomized into three different study groups: one group will receive two enemas containing RBX2660; another group will receive two enemas without the active drug; and the third group will receive one enema with RBX2660 and one without. If a patient’s C. diff. infection reoccurs before 8 weeks after treatment, he or she may be eligible to crossover to receive active treatment with RBX2660.
All patients will be followed for 24 months after treatment.
Further Study Details
For more information on the study you may:
- Download the PUNCH CD 2 clinical study patient brochure (PDF 1.6 MB).
- View clinical study details at clinicaltrials.gov
Find Out if You Could be Eligible
A physician participating in the PUNCH CD 2 study will determine if you are eligible to participate in the study. However, you can take a brief survey (less than 1 ½ minutes to complete) to learn if you meet the major study eligibility criteria.
How to Enroll as a Participant
If a study physician thinks you may be a good candidate, you will be given complete information about the study including the responsibilities for participation. You can find out if there is a study site near you by reviewing the clinical study site locations for PUNCH CD 2.
|Caution: New Drug – Limited by Federal (or United States) law to investigational use.
*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.