announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID ® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides ) difficile infections (CDI) in children aged six months or older. Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020. The investigational pediatric indication for DIFICID was granted Orphan Drug Designation (ODD) in 2010.
“Evidence indicates the increasing incidence of C. difficile -associated diarrhea among hospitalized children 1,” said Dr. Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories. “The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.”
The sNDA is based primarily on results of the Phase 3 SUNSHINE study 2, which were presented as part of the Late Breaker Oral Abstracts on Emerging Infections at IDWeek 2018 in San Francisco, California.
About DIFICID (fidaxomicin)
DIFICID is a macrolide antibacterial medicine indicated in adults (18 years of age or older) for treatment of Clostridium difficile -associated diarrhea (CDAD). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridiumdifficile. DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID. DIFICID should only be used for the treatment of C. difficile-associated diarrhea. DIFICID is not effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.
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Dr. Peter Marks, director the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration stated, “While we support this area of scientific discovery, it’s important to note that fecal microbiota for transplantation does not come without risk,”
Two patients contracted severe infections, and one of them died, from fecal transplants that contained drug-resistant bacteria.
The agency said two patients received donated stool that had not been screened for drug-resistant germs, leading it to halt clinical trials until researchers prove proper testing procedures are in place.
After reports of serious, antibiotic-resistant infections linked to the procedures, the FDA wants “to alert all health care professionals who administer FMT [fecal microbiota transplant] about this potential serious risk so they can inform their patients.” said Dr. Peter Marks, director the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration.
Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms (MDRO). They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which makes them resistant to multiple antibiotics. The stool had not been tested for the germs before being given to the patients.
The F.D.A. on Thursday issued a warning to researchers that stool from donors in studies of fecal transplantation should be screened for drug-resistant microbes, and not used if those were present. It is also warning patients that the procedure can be risky, is not approved by the agency and should be used only as a last resort when C. difficile does not respond to standard treatments.
Dr. Marks said the agency was trying to strike a balance between giving patients who need the treatment access to it while also establishing safeguards to protect them from infection. In a statement, he said, “While we support this area of scientific discovery, it’s important to note that fecal microbiota for transplantation does not come without risk.”
Researchers are also looking into the use of fecal transplants to treat chronic gastrointestinal illnesses such as ulcerative colitis or irritable bowel syndrome.
The patients received treatment as part of a clinical trial, and the researchers conducting the trial reported the cases as adverse events to the F.D.A., which they are required to do. But the rules governing this kind of experiment prohibit the F.D.A. from revealing details about the treatment or who provided it.
Health care facilities everywhere have been ramping up their disinfection practices in order to prevent the spread of infectious diseases. However, when it comes to hospital mattresses, one of the biggest vectors for spreading deadly bugs, efforts are still falling short.
With health care workers using chemicals that are intended for dry surfaces, the mattresses are harboring pathogens such as Clostridium difficile (C. diff), and, as Edmond A. Hooker, MD, DrPH, professor in the Department of Health Administration at Xavier University, pointed out at the 5th Annual International C. diff Awareness & Health Expo, regulatory agencies seem to have “turned a blind eye” to the issue.
The US Food and Drug Administration (FDA) recently released a notice on how to keep hospital mattress covers safe.
In this notice, the FDA notes safety concerns regarding hospital mattress covers, particularly that over time they can “wear out and allow blood and body fluids to penetrate and get trapped inside mattresses.” They added, “If blood or body fluids from one patient penetrate and get absorbed in a mattress, the fluids can leak out the next time the mattress is used.” If that happens, the next patient runs the risk of coming into contact with these fluids, and thus, becoming infected with pathogens from the bed’s previous occupants.
The FDA reports that this is not the first time they acknowledged these concerns; they released a safety communication in 2013 to make health care workers aware of the issue. However, the problem of contaminated hospital mattresses persists.
“There is no question there has been report after report after report of, ‘We had this outbreak. We killed all these people.’ There was just a report that came out on 18 people who were sick in a French hospital; they were on beds manufactured here in America, and 4 people were killed before they finally realized that it was the mattresses. They took all of the mattresses out of service and stopped the outbreak,” Dr. Hooker told Contagion® in an exclusive interview.
“There’s a reason that it’s an under reported problem; hospitals don’t want to say, ‘Hey, we just killed a bunch of people. We kill 29,000 people a year with C. difficile infections. Do you hear that? I mean, that’s like crashing a plane every day and we do nothing about it. We just act like it didn’t happen.”
In an effort to address the issue, the FDA has released recommendations based on Centers for Disease Control and Prevention (CDC) guidelines for environmental infection control in health care facilities; they include:
Develop an inspection plan for all hospital mattresses and mattress covers in the facility. Learn the time of life for all mattresses/mattress covers by checking the manufacturer’s guidelines; follow any other recommendations that the manufacturers list. If you have any additional questions, contact the mattress manufacturer.
Inspect each hospital mattress for visible signs of damage, which can include: cuts, tears, cracks, pinholes, snags, or stains. On a routine basis, remove mattress covers and check the inside. With the cover removed, check the mattress for wet spots, staining, or other signs of damage. Be sure to check all sides of the mattress as well as underneath. You will not be able to effectively inspect the mattress with the cover on.
Remove any mattresses that are damaged, appear worn, or are visibly stained and immediately replace any mattress covers that are damaged.
Maintain your mattresses and mattress covers by cleaning and disinfecting them “according to the manufacturer’s guidelines.” DO NOT stick needles into the hospital mattress through the cover, the FDA stresses.
“The FDA notice about mattress failures is an important first step. However, much more needs to be done. Most failures are not being reported to FDA, and the 700 reports that they have represents an industry-wide problem. Up to one-third of hospital mattresses currently in service in hospitals have failed. Also, the ones that have not failed are not being cleaned,”
Dr. Hooker stressed to Contagion® in a follow-up interview. “These mattresses quickly get fissures and microscopic cracks that allow bacteria to remain on the surface during terminal cleaning. The next patient is then exposed to those bacteria and gets a hospital-acquired infection. The CDC needs to mandate better cleaning practices nationwide, which they can do.
The CDC needs to also mandate inspection of every mattress after every patient. Damaged mattresses should be removed from service immediately.”
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The media and publications are raising
FMT awareness .
The positive effects are being
noted as FMT’s hold a promising treatment option and success is being witnessed in patients suffering
through C. diff. infections.
Being treated by a physician with a Fecal Microbiota Transplantation, to treat recurrent Clostridium difficile infections, is resolving the pain and torment being experienced by patients.
What is a Fecal Microbiota Transplant (FMT)?
Fecal microbiota transplants (FMTs) are exactly what they sound like.
They involve taking feces from a healthy person and putting them into the body
of a sick patient to strengthen the community of bacteria that live in the patient’s gut.
FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff).
The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome. (1)
However; this treatment – in any form – has not yet been approved by the U.S. Food and Drug Administration (FDA).
Clinical data is pending and FMT remains investigational at this time.
Below is the link to the FDA website and the March 2014 document regarding
Fecal Microbiota Transplantation (FMT) for the general public:
Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.
III. When FDA Intends to Exercise Enforcement Discretion
FDA does not intend to exercise enforcement discretion for the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by either the patient or the licensed health care provider treating the patient, or when the donor and donor stool are not qualified under the direction of the treating licensed health care provider.
FDA will continue to evaluate its enforcement policy.
Furthermore, during the period of enforcement discretion, FDA will continue to work with sponsors who intend to submit INDs for use of FMT to treat C. difficile infection not responding to standard therapies.
This enforcement discretion policy does not extend to other uses of FMT. Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are more limited, and study of FMT for these other uses is not included in this enforcement policy. (2)
* Also, click on the link below to view the US Food and Drug Administration (FDA)