Tag Archives: c diff

CutisPharma Announces FDA Approval Of FIRVANQ™ (vancomycin hydrochloride) for Oral Solution for Treatment of Clostridium difficile Associated Diarrhea (CDAD) and Staphylococcus aureus Colitis

CutisPharma Announces FDA Approval Of FIRVANQ™ For Treatment Of  Clostridium Difficile Associated Diarrhea (CDAD) And Staphylococcus Aureus Colitis

 

FDA-approved vancomycin oral liquid therapy expected to improve patient access and reduce pharmacist  burden by no longer having to compound liquid formulations

CutisPharma announced today, January 29, 2018,  that the US Food and Drug Administration (FDA) has approved FIRVANQ™ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

“We are pleased to announce the FDA approval of FIRVANQ,” said Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma. “FIRVANQ’s approval is an important step forward to providing patients the only FDA-approved vancomycin oral liquid treatment option for Clostridium difficile associated diarrhea, a life-threatening condition that affects over a half-million patients in the United States annually.”

Upon its launch, which is targeted to be April 2, 2018, FIRVANQ™ will replace CutisPharma’s FIRST®-Vancomycin Unit-of-Use Compounding Kit, which has been available to pharmacists that need a convenient, accurate, and compliant way to compound vancomycin oral liquid therapy. FIRVANQ™ will be commercially available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes.  FIRVANQ™ is designed to be easy to use and has the potential to be a cost-effective alternative to existing vancomycin therapies.

“As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” said Stuart Johnson, MD, Loyola University Medical Center. “Patient access is currently limited by the fact that only a select few pharmacies perform compounding in the outpatient setting these days, given the many new regulations in place.  Availability of an FDA-approved vancomycin oral liquid treatment will effectively allow any pharmacy to stock this therapy, and hopefully encourage third-party payer reimbursement, significantly improving accessibility and convenience for patients.”

About CutisPharma

CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company that has been the industry leader for 20 years in providing innovative solutions to pharmacists.  CutisPharma’s FIRST® Unit-of-Use Compounding Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by commercially available therapies. The Company’s first FDA-approved Kit will allow significantly broader patient access, convenience to pharmacists and patients alike by reducing the need for compounding, and serve as a potential cost-saving option to existing treatments.  For more information, visit www.cutispharma.com

Zinplava has been launched by MSD in the UK

MSD has launched Zinplava in the UK, offering patients a novel therapeutic option for the prevention of Clostridium difficile recurrence.

Zinplava (bezlotoxumab) is not an antibacterial and is not indicated to actually treat the infection, but is a monoclonal antibody designed to neutralise C. difficile toxin B, which can damage the gut wall and cause inflammation, leading to diarrhoea.

It is the first and only EC licensed non-antibiotic option indicated to prevent recurrence of Clostridium difficile infection (CDI) in high-risk adults.

Around one-in-four patients experience a recurrence after the initial episode, and more than 40 percent of these have further recurrence, highlighting the need for new options able to break the infection cycle.

Pivotal Phase III clinical studies showed the rate of infection recurrence through week 12 to be significantly lower in patients given Zinplava (17.4 percent and 15.7 percent) or Zinplava and actoxumab (15.9 percent and 14.9 percent) than those taking a placebo (27.6 percent) and (25.7 percent), respectively.

“Notably, bezlotoxumab reduces the risk of the recurrence of CDI for at least 3 months, compared with standard of care antibiotic therapy. This is welcome addition to our limited options to reduce the considerable morbidity and mortality associated with CDI,” commented Mark Wilcox, Professor of Medical Microbiology at the University of Leeds.

“Antimicrobial resistance is a key national issue and we hope with bezlotoxumab to not only help achieve a reduction in the number of recurrent episodes of CDI but also a reduction in the amount of antibiotic prescriptions that would otherwise be needed to treat these recurrent episodes,” added Dr Mike England, MSD’s Interim Medical Director.

Zinplava is administered as a single, one-off, one-hour intravenous infusion alongside standard-of-care antibiotic therapy for the treatment of CDI.

 

C Diff Foundation and C diff Survivors Alliance Network Share a Winter 2017 Bulletin

Greetings from the main office of the C Diff Foundation and the C diff Survivors Alliance Network located in New Port Richey, Florida.  As we close 2017 we mark the 5th anniversary of the two organizations. We want to share with you a summary and reflection on this year’s events and campaigns moving our mission forward and message delivered worldwide. The mission and promoting C.diff. Awareness has been shared this year with  listeners in over 25 Counties during Season III on C. diff. Spores and More Global Broadcasting Network (www.cdiffradio.com),  5,000+ visitors during global events, 9,600+ residents and business owners throughout villages and communities by our dedicated volunteer patient advocates, to over 1,000 clinicians who received up-to-date data expanding their knowledge during workshops and local symposiums offered worldwide, 3,000+ incoming calls received through the Nationwide Hot-Line 1-844-FOR-CDIF with the thousands of e-mails received seeking assistance.

After each event, workshop, meeting, introduction we thank the individuals for sharing  in five years of opportunity to provide life-saving data educating and advocating for C. difficile infection prevention, treatments, environmental safety and support worldwide.  The mission of the C Diff Foundation is the momentum of charity that has proven effective and grown over the past five years.  A single act of charity grows into more and greater charity worldwide.  The work each member of the C Diff Foundation, with hundreds of Volunteer Patient Advocates, promote the Foundation’s mission which never stops with a single act.  Instead, it builds, it grows, and it expands into an exponential impact of good in the world helping to save lives.  We thank you for your continued support and encourage you to continue your journey, proposing three verbs important to the C Diff Foundation and the C diff Survivors Alliance Network in general.

The first of these verbs is “to promote” C.diff. Awareness. It is the first step that opens doors in educating individuals, clinicians, communities in learning more about this life-threatening infection which causes a great amount of pain and suffering around the globe.  It is essential and it is the compass in reaching shared goals.

The second verb is “to heighten awareness” across the nation to continue proclaiming November Clostridium difficile infection awareness month. The Governors proclaimed November C. difficile (C.diff) infection awareness month in 2017 and we encourage them “to welcome” this proclamation in 2018 with more than a yearly executive order of greeting or inviting their residents to take notice.  We look forward to working with delegates, with your support, to make this proclamation statement nationwide and welcome the importance of the time, education, programs, and agenda in place addressing this life-threatening infection.  The C Diff Foundation advocates and supports the individuals and families suffering during and after being treated for a C. diff. infection.

Finally, the third verb that the C Diff Foundation and C diff Survivors Alliance Network propose is “to go.”  Here we are all challenged to do something big or small — with what we are able to do.  With the unity of members with volunteers with patients, families, and clinicians we can make a difference with enthusiasm and simplicity to get up and go.  We can do for others  today what we could not do for ourselves during our time of illnesses, during the long periods of isolation, during the losses, and during the pain and suffering.

As members of the C Diff Foundation we know that our enthusiasm  for our mission is the desire to bring awareness and promote C. difficile infection prevention, treatments, environmental safety and support worldwide.  We witness changes by the data and information being delivered within villages,  through major cities and in small communities — it is only by taking this path that we gain satisfaction knowing that the news delivered with enthusiasm “to promote, to heighten awareness and to go” with the members and volunteers in the C Diff Foundation and C diff Survivors Alliance Network creates positive results.

We are truly grateful for your continued dedication, efforts and support and thank you again for making this year’s November anniversary such a special occasion through the growth and advances made worldwide.   Let’s carry the mission into the New Year, carving new paths to witness the decline of newly diagnosed cases of Clostridium difficile (C.diff., C. difficile) infections and saving lives worldwide.

“None of us can do this alone ~ All of us can do this together.”

 

 

Medicare Penalties Include Antibiotic-Resistant Bacteria In Hospital Patient Injury Reporting

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The federal government has cut payments to 769 hospitals with high rates of patient injuries, for the first time counting the spread of antibiotic-resistant germs in assessing penalties.

The punishments come in the third year of Medicare penalties for hospitals with patients most frequently suffering from potentially avoidable complications, including various types of infections, blood clots, bed sores and falls.

This year – 2016 –  the government also examined the prevalence of two types of bacteria resistant to drugs.

Based on rates of all these complications, the hospitals identified by federal officials this week will lose 1 percent of all Medicare payments for a year — with that time frame beginning this past October. While the government did not release the dollar amount of the penalties, they will exceed a million dollars for many larger hospitals. In total, hospitals will lose about $430 million, 18 percent more than they lost last year, according to an estimate from the Association of American Medical Colleges.

The reductions apply not only to patient stays but also will reduce the amount of money hospitals get to teach medical residents and care for low-income people.

Forty percent of the hospitals penalized this year – 2016 – escaped punishment in the first two years of the program, a Kaiser Health News analysis shows. Those 306 hospitals include the University of Miami Hospital in Florida, Cambridge Health Alliance in Massachusetts, the University of Michigan Health System in Ann Arbor and Mount Sinai Hospital in New York City.

Nationally, hospital-acquired conditions declined by 21 percent between 2010 and 2015, according to the federal Agency for Healthcare Research and Quality, or AHRQ. The biggest reductions were for bad reactions to medicines, catheter infections and post-surgical blood clots.

Still, hospital harm remains a threat. AHRQ estimates there were 3.8 million hospital injuries last year, which translates to 115 injuries during every 1,000 patient hospital stays during that period.

Each year, at least 2 million people become infected with bacteria that are resistant to antibiotics, including nearly a quarter million cases in hospitals. The Centers for Disease Control and Prevention estimates 23,000 people die from them.

Infection experts fear that soon patients may face new strains of germs that are resistant to all existing antibiotics. Between 20 and 50 percent of all antibiotics prescribed in hospitals are either not needed or inappropriate, studies have found. Their proliferation — inside the hospital, in doctor’s prescriptions and in farm animals sold for food — have hastened new strains of bacteria that are resistant to many drugs.

One resistant bacteria that Medicare included into its formula for determining financial penalties for hospitals is methicillin-resistant Staphylococcus aureus, or MRSA, which can cause pneumonia and bloodstream and skin infections. MRSA is prevalent outside of hospitals and sometimes people with it show no signs of disease. But these people can bring the germ into a hospital, where it can be spread by health care providers and be especially dangerous for older or sick patients whose immune system cannot fight the infection.

Hospitals have had some success in reducing MRSA infections, which dropped by 13 percent between 2011 and 2014, according to the CDC. AHRQ estimates there were 6,300 cases in hospitals last year.

The second bacteria measured for the penalties is Clostridium difficile, known as C. diff, It can be spread through contaminated surfaces or hands. ………,

C. diff has challenged infection control efforts. While hospital infections dropped 8 percent from 2008 to 2014, there was a “significant increase” in C. diff that final year, the CDC says. AHRQ estimated there were 100,000 hospital cases last year.

“The reality is we don’t know how to prevent all these infections,” said Dr. Louise Dembry, a professor at the Yale School of Medicine and president of the Society for Healthcare Epidemiology of America.

The Hospital-Acquired Condition Reduction Program also factors in rates of infections from hysterectomies, colon surgeries, urinary tract catheters and central line tubes. Those infections carry the most weight in determining penalties, but the formula also takes into account the frequency of bed sores, hip fractures, blood clots and four other complications.

Specialized hospitals, such as those that treat psychiatric patients, veterans and children, are exempted from the penalties, as are hospitals with the “critical access” designation for being the only provider in an area. Of the remaining hospitals, the Affordable Care Act requires that Medicare penalize the 25 percent that perform the worst on these measures, even if they have reduced infection rates from previous years.

…………………

To read the article in its entirety click on the following link to be redirected:

http://triblive.com/news/healthnow/11702788-74/hospitals-hospital-penalties

FDA Grants Qualified Infectious Disease Product and Fast Track Designation To Morphochem’s IV Antibacterial Product Candidate MCB3837 To Treat C.diff. Infections

Morphochem is a clinical-stage pharmaceutical company, announced July 25, 2016 that the U.S. Food and Drug Administration (FDA) has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI).

At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, the QIDP designation provides certain incentives for the development of new antibacterial drug products, such as priority review and additional five years of marketing exclusivity granted at the time of marketing approval. The Fast Track designation enables more frequent interactions with the FDA, often leading to earlier drug approval and access for patients.

“After the U.S. FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837” says Thomas Kapsner, M.D., Morphochem’s Chief Executive Officer. “These designations will help us to expedite the development of this promising IV compound for the many severely ill CDI patients who cannot be treated orally. By providing an effective IV therapy, we aim to improve the prospects and quality of life of these patients.”

Morphochem is planning to initiate a proof-of-concept Phase 2 clinical trial of MCB3837/3681 in severe CDI patients in H2 2016.

About MCB3837/MCB3681 MCB3837 is a water-soluble injectable small-molecule prodrug of the active substance MCB3681, which is being developed for the IV treatment of CDI. Three Phase 1 clinical studies have proved MCB3837/MCB3681 to be safe and tolerable. In pre-clinical studies, MCB3681 demonstrated remarkable Gram-positive antimicrobial activity against C. difficile pathogens including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial.

In a multiple-dose Phase 1b study with healthy volunteers, high fecal concentrations of MCB3681 were observed resulting in a pronounced effect on clostridia and other Gram-positive species while sparing Gram-negative species, including the bacteroides that protect the intestine against colonization with harmful pathogens potentially causing gastrointestinal infections. Due to this strong pharmacodynamic effect in humans, its narrow Gram-positive spectrum, and its favorable impact on the commensal flora, MCB3681 has the potential to target C. difficile pathogens selectively and effectively.

 

Key risk factors for developing CDI include the use of antibiotics (as they suppress the normal bowel flora) and advanced age. Up to 40 percent of patients develop severe / severe and complicated CDI, associated with significantly higher morbidity and mortality rates. Treatment is currently dominated by oral therapies which, however, tend to prove ineffective for severely ill patients as they often have difficulties swallowing or digesting tablets, or problems retaining the oral medication in or moving it along the gastrointestinal tract. Alternatives are limited, as there is no approved IV therapy available at present.

About Morphochem Morphochem Aktiengesellschaft für kombinatorische Chemie is a private clinical-stage pharmaceutical company located in Munich, Germany. Morphochem is a 100-percent subsidiary of Biovertis AG, headquartered in Vienna, Austria.  Biovertis’s major shareholder is TVM Capital Life Science.  Morphochem is fully dedicated to the development and commercialization of MCB3837/MCB3681, which the company hopes to introduce as the first approved intravenous therapy for severe Clostridium difficile infections.

To read the article in its entirety click on the link below:

http://www.einnews.com/pr_news/336679603/fda-grants-qidp-and-fast-track-designations-to-mcb3837-morphochem-s-novel-intravenous-antibacterial-to-treat-c-difficile-infections

 

NEW Clorox Healthcare Fuzion Cleaner Disinfectant Kills 36 Microorganisms, Including C. difficile Spores, In 2 Minutes Or Less

Fuzion-hero-centered-new

CLOROX HEATLHCARE

Kills 36 Microorganisms in 2 Minutes or Less

Now You Can Use Bleach in More Places than Ever Before     HEALTHCARE

A next-generation bleach product that kills C. difficile spores in 2 minutes, has broad surface compatibility for everyday use, and has a low odor that disappears within minutes.

Use Sites and Applications

Medical: Autoclaves, bedrails, bedside tables, carts, counters, computer screens, diagnostic equipment, dialysis machines, glucometers, gurneys, IV pumps, patient monitoring equipment, plastic mattress covers, remote controls, shower fixtures, stretchers, toilet handholds, walls around toilet/patient rooms, wash basins, wheelchairs, x-ray equipment

  • Dental: Countertops, dentist chairs, endodontic equipment, instrument trays, light lens covers, operatory surfaces, reception counters/desks
  • Veterinary: Animal equipment, transportation vehicles, veterinary care surfaces
  • General Use/Miscellaneous surfaces: Bed frames, doorknobs, hand railings, changing tables, highchairs, playpens, bath tubs, sinks and toilets

 

Directions for Use

  1. REMOVE gross soil if visible. For C. difficile spores and TB, always clean surface prior to disinfecting.
  2. SPRAY 6″–8″ from surface until surface is completely wet.
  3. To DISINFECT, let stand for 1 minute. To kill C. difficile spores, allow 2 minutes contact.
  4. WIPE with a clean, damp cloth. Allow to air dry.

CAUTION: Moderate eye irritant. Do not get in eyes or on clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or going to the toilet.

Click on the link below to be redirected to the Clorox Healthcare website:

https://www.cloroxprofessional.com/products/clorox-healthcare-fuzion-cleaner-disinfectant/at-a-glance/

  • Please Contact CLOROX HEALTHCARE with any questions or concerns regarding Clorox products.

 

NOTE:  The C Diff Foundation Does Not Endorse or Promote Any Products Or Services Shared On This Website, This Posting Is Strictly For Information Purposes Only.

PODCAST of June 28th C. diff. Spores and More With Guests Dr. Sliman & Dr. Pimentel As We Discuss Synthetic Biologics: Protecting the Gut Microbiome and Maintaining Human Health

 

Listen to the PODCAST of the live broadcasted

on  June 28th,  2016

cdiffRadioLogoMarch2015CLICK ON THE LOGO TO BE REDIRECTED TO THE PODCAST OF THE LIVE BROADCAST

Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

Synthetic Biologics: Protecting the Gut Microbiome
and Maintaining Human Health

With Our Guests:

Dr. Joseph Sliman, MD
Senior Vice President, Clinical & Regulatory Affairs

Dr. Mark Pimentel, MD, FRCP(C)
Director of the GI Motility Program and Laboratory at Cedars-Sanai

On Tuesday, June 28th  we discussed public awareness of the microbiome and its link to human health – is on the rise as evidenced by recent government-sponsored programs such as the National Microbiome Initiative.  Protection of the natural gut microbiome from the unintended consequences of intravenous (IV) antibiotics, which are excreted into the gut, is expected to protect against opportunistic enteric infections.   Recent clinical data suggest that the absence or abundance of certain microbes may be directly linked to certain infections and diseases including a Clostridium difficile infection (CDI), and irritable bowel syndrome (IBS).   Synthetic Biologics is developing two microbiome-focused drug candidates in Phase 2 development including SYN-004 which is designed to protect the gut microbiome by degrading certain IV beta-lactam antibiotics for the prevention of a CDI, antibiotic associated-diarrhea (AAD) and the emergence of antibiotic-resistant organisms.  And SYN-010 is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).   Synthetic Biologics Inc.’s Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs with Mark Pimentel, MD, FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, will be discussing both the Company’s novel microbiome-focused product candidates.

 

MORE ABOUT OUR GUESTS:

Dr Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs.

Dr. Sliman joined Synthetic Biologics in January 2013 as the Senior Vice President, Clinical & Regulatory Affairs. In this position, Dr. Sliman will be responsible for the design and implementation of all aspects of clinical development, including clinical trials, and will lead the Company’s regulatory initiatives. During his service in the United States Navy, Dr. Sliman led the U. S. Pacific Fleet disease surveillance programs, including influenza surveillance, preparedness, and prevention, as well as communicable disease and injury surveillance and prevention and health policy development. Dr. Sliman earned an M.D. from the Uniformed Services University, a Master’s Degree in Public Health from the Johns Hopkins University School of Public Health, and a B.S. in Molecular and Cell Biology, with Honors in Biology, from Pennsylvania State University

Dr Mark Pimental, MD, FRCP(C), Director of the GI Motility Program and
Laboratory at Cedars-Sanai.

Mark Pimentel, MD, FRCP(C), is Director of the GI Motility Program and
Laboratory at Cedars-Sinai, Associate Professor of Medicine at CSMC and Professor of Medicine at UCLA Geffen School of Medicine in Los Angeles, CA. Dr. Pimentel completed three years of undergraduate degree with honors in microbiology and biochemistry at the University of Manitoba, Canada. This was followed by his medical degree and his BSc(Med) from the Univeristy of Manitoba Health Sciences Center in Winnipeg, Manitoba, Canada where he also completed a residency in internal medicine. His medical training includes a fellowship in gastroenterology at the UCLA Affiliated Training Program. Active in research Dr. Pimentel has served as a principal investigator or co-investigator for numerous basic sciences, transitional, and clinical studies in such areas as IBS, and the relationship between gut flora composition and human disease.

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C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

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 HeZarPhotoWebsiteTop (2)ad 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.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

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