SAVE THE DATES to listen in to the leading topic expert presentations
shared on January 15, 2021, at the Patient, Family, Caregiver Symposium:
Beginning Tuesday, March 9 from 1:00 p.m. – 2:00 p.m. EST following through on
March 16, March 23, and March 30.
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers.
The Patient & Family C. diff. Symposium was a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, thought leaders, and patients who are transforming the patient experience and changing the way people experience C. diff. infections worldwide.
Unlike other conferences on this topic, patients will share their C. diff. infection journeys, providing a real-world perspective on patient experience. Our attendees will learn more from this virtual-online symposium and gain knowledge on important topics that will better aid their care and recovery through tools and strategies delivered by keynote speakers.
The Symposium followed the C Diff Foundation Mission statement – Educating and Advocating for the prevention, treatments, clinical trials, diagnostics, and environmental safety of Clostridioides difficile (C. diff.) infections worldwide.
Keynote speakers presented up-to-date data to expand on the existing knowledge and provide important information focused on, yet not limited to, a Clostridioides difficile infection (also known as C. diff., C. difficile, CDAD, CDI) ……
Clinical trials and studies
Introduction to Microbiome Research and Studies
Fecal Microbiota Restoration and Transplants
We hope you enjoy the broadcasts!
Program Chair: Paul Feuerstadt, MD, FACG
Barbara McGovern, MD “Treatment of recurrent C. difficile infection with SER-109, an investigational microbiome drug.”
Paul Feuerstadt, MD ” C. diff. Overview – What is a C. diff. Infection?”
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced on January 27, 2020, that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment ofClostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.1
DIFICID is a macrolide antibacterial medicine indicated in adults and pediatric patients aged 6 months and older for the treatment of 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 Clostridioides difficile (C. difficile).
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 CDAD. DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.
“C. difficile is an important cause of health care- and community-associated diarrheal illness in children and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children,” said Dr. Larry K. Kociolek, Associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children’s Hospital of Chicago. “I am very excited to have a new C. difficile infection treatment option for my pediatric patients.”
“Merck is committed to developing new treatments, as well as expanding indications of existing ones, in order to provide more solutions to treat infectious diseases, particularly among children,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “C. difficile infection is an urgent public health challenge. We are grateful to the health care practitioners, the patients and their families for their invaluable contributions in helping to bring this new pediatric indication and the oral suspension formulation for DIFICID to the U.S. market.”
Both applications received a priority review classification by the FDA. The investigational pediatric indication for DIFICID was granted Orphan Drug Designation in 2010.
Data Supporting the Approval of DIFICID in Pediatric Patients
The FDA’s approval of the new formulation and new indication for DIFICID was based on a Phase 3, multicenter, investigator-blind, randomized, parallel-group study (known as the SUNSHINE study, NCT02218372), in which the safety and efficacy of fidaxomicin was evaluated in pediatric patients from 6 months to less than 18 years of age (one patient was less than six months of age). This study, sponsored by Astellas Pharma Europe B.V. (with Merck & Co., Inc. as collaborator) included 148 randomized patients aged <18 years with confirmed CDI, of whom 142 received either fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, four times daily) in a 2:1 ratio. Patients were randomized by age group, as follows: 30 patients from 6 months to <2 years; 49 patients age 2 to <6 years, 40 patients age 6 to <12 years and 29 patients age 12 to <18 years. Generally, the two treatment groups were balanced regarding demographics and other baseline characteristics. CDAD clinical response in the overall pediatric population, assessed through two days following 10 days of treatment, was similar between the fidaxomicin and vancomycin groups (77.6% vs. 70.5% with a 95% CI for the treatment difference of 7.5 [-7.4%, 23.9%]). Sustained clinical response, defined as the proportion of treated patients with confirmed clinical response and no CDAD recurrence through 30 days after the end of treatment, was higher for fidaxomicin than for vancomycin (68.4% vs. 50.0% with a 95% CI for the treatment difference of 18.4 [1.5%, 35.3%]).
The safety of DIFICID in pediatric patients 6 months to less than 18 years of age was evaluated in a Phase 2 single-arm trial in 38 patients and a Phase 3 randomized, active-controlled trial in 98 patients treated with DIFICID and 44 patients treated with vancomycin. Treatment discontinuation due to adverse reactions occurred in 7.9% (3/38) of patients in the Phase 2 trial, and in 1% (1/98) and 2.3% (1/44) of DIFICID- and vancomycin-treated patients, respectively, in the Phase 3 trial. The most common selected adverse reactions occurring in ≥5% of pediatric patients treated with DIFICID in the Phase 3 trial were pyrexia (13.3%), abdominal pain (8.2%), vomiting (7.1%), diarrhea (7.1%), constipation (5.1%), increased aminotransferases (5.1%) and rash (5.1%). One death occurred in the Phase 2 single-arm trial and three deaths occurred in the Phase 3 trial of DIFICID-treated patients. No deaths occurred in vancomycin-treated patients during the study period (40 days). All deaths occurred in patients less than 2 years of age and appeared to be related to underlying comorbidities.
Clostridioides (formerly Clostridium)difficile, also known as C. difficile or C. diff, is one of the most common causes of healthcare-associated infections in U.S. hospitals.2 Recent estimates suggest C. difficile causes almost 500,000 infections annually in the United States and is associated with approximately 29,000 deaths within 30 days of initial diagnosis.3 According to the CDC’s Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report), C. difficile is categorized as an urgent threat and is stated as a public health threat that requires urgent and aggressive action.4
Important Safety Information about DIFICID (fidaxomicin)
DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with DIFICID. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systematic absorption of fidaxomicin. DIFICID has not been studied for the treatment of infections other than CDAD. DIFICID should only be used for the treatment of CDAD.
Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
The most common adverse reactions reported in adults are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
The most common adverse reactions in pediatric patients are pyrexia (13.3%), abdominal pain (8.2%), vomiting (7.1%), diarrhea (7.1%), constipation (5.1%), increased aminotransferases (5.1%) and rash (5.1%).
Among patients receiving DIFICID (fidaxomicin), 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for both DIFICID and vancomycin patients).
The safety and effectiveness of DIFICID have not been established in pediatric patients younger than 6 months of age.
The recommended dose for adults is one 200 mg DIFICID tablet orally twice daily for 10 days, with or without food.
The recommended dose for pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg DIFICID tablet administered orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension based on weight. DIFICID oral suspension should be administered orally twice daily for 10 days.
No dose adjustment is recommended for patients 65 years of age or older.
No dose adjustment is recommended for patients with renal impairment.
No dosage adjustments are recommended when co-administering DIFICID with substrates of P-gp or CYP enzymes.
The impact of hepatic impairment on the pharmacokinetics of DIFICID has not been evaluated; however, because DIFICID and its active metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, elimination of DIFICID and OP-1118 is not expected to be significantly affected by hepatic impairment.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs, and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2018 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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.
To review the article in its entirety click on the following link to be redirected. Thank you.
Like any medication, antibiotics carry certain risks. While they are critical to treating a wide range of conditions, from strep throat and urinary tract infections to bacterial pneumonia and sepsis, these drugs also increase a patient’s chances of developing Clostridium difficile infections—which can result in life-threatening diarrhea—and can lead to adverse drug events, including allergic reactions.
Because of these dangers, it is important to use antibiotics only when needed. However, many antibiotics prescribed in the United States are unnecessary.
See what the research tells us and what leading antibiotic use experts say about inappropriate prescribing, the threat it poses to patient health, and how improved antibiotic stewardship can help to protect patient safety.
Improving Outpatient Antibiotic Use: The Role of Pediatricians
“For a long time, we believed that ‘erring on the safe side’ for our patients might be to prescribe an antibiotic just in case, even when we weren’t completely certain of the diagnosis. … Increasingly, we’re realizing that ‘being on the safe side’ often means not prescribing an antibiotic.”
Improving Outpatient Antibiotic Use: The Role of Emergency Room Doctors
“Acute bronchitis is one of the very common conditions we see in the emergency department and it’s also one … for which we have the best evidence that antibiotics should not be used, as these infections are typically caused by viruses and will resolve on their own. … I’ve seen … patients that received antibiotics for simple bronchitis or sinusitis that probably didn’t need the antibiotic, and then came in with life-threatening diarrheal illness, known as C. difficile infection.”
Improving Outpatient Antibiotic Use: The Role of Primary Care Physicians
“There’s a misperception on the part of doctors that patients want antibiotics. … [There] are millions of individual visits where we’re doing the wrong thing by our patients. We’re giving them medicines that they don’t need.”
One study estimated that a 30 percent reduction in broad-spectrum antibiotic use in hospitals could result in a 26 percent reduction in hospital-associated C. difficile infections.
Improving Outpatient Antibiotic Use: The Role of Nurse Practitioners
“What is concerning is a lot of people think every sore throat is strep throat, and they want antibiotics. The reality is that most sore throats are not strep throat. It is important that we make sure that we don’t give antibiotics just for a viral sore throat. … If we continue to prescribe antibiotics inappropriately … we will get to a point where children are not responding to antibiotics. And that’s very scary.”
The C Diff Foundation today announced that it presented CutisPharma, Inc., its “Making a Difference” award as a special recognition of the significant contribution that CutisPharma has made to the C.diff. Community: helping the advancement of C.diff. awareness as well as expanding treatment options for C.diff. patients.
C Diff Foundation’s ‘Making a Difference’ Award Presented at CutisPharma’s Pre-Launch Celebration for Newly Approved C.diff. Drug FIRVANQ
(NEW PORT RICHEY, Fla.) — NEWS: The C Diff Foundation announced today that it presented CutisPharma, Inc., its “Making a Difference” award as a special recognition of the significant contribution that CutisPharma has made to the C.diff. Community: helping the advancement of C.diff. awareness as well as expanding treatment options for C.diff. patients.
The award was presented at CutisPharma’s celebration of its upcoming launch of FIRVANQ(TM), recently approved by the FDA for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Upon launch, FIRVANQ(TM) will be the only FDA-approved oral vancomycin solution treatment commercially available, improving patient access and reducing pharmacist burden by no longer having to compound oral liquid formulations.
“CutisPharma has been a committed partner of our Foundation and has furthered our mission to increase C.diff. awareness and support the research and development of new treatment options,” said Nancy C. Caralla, Foundress and Executive Director of the C Diff Foundation. “In recognition of CutisPharma’s efforts, we are pleased to grant them the ‘Making a Difference’ award at this special moment in the Company’s 20th anniversary year.”
“We are very grateful to receive such a special distinction from the C Diff Foundation,” said Neal I. Muni, MD, MSPH, and Chief Executive Officer of CutisPharma. “For 20 years, we have been committed to improving the lives of patients who are not well-served by existing therapies and would benefit from high-quality, cost-effective new treatment options. We greatly value our partnership with the C Diff Foundation and look forward to continuing to support their mission.”
In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.) infections in a single year according to a study released in 2015 by the Centers for Disease Control and Prevention (CDC). Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections making C. difficile a very important cause of infectious disease death in the United States.
About the C Diff Foundation:
The C Diff Foundation, a 501(c)(3)non-profit organization, established in 2012, is comprised of 100 percent volunteering professionals dedicated to supporting public health initiatives for C. difficile infection prevention, treatments, environmental safety, and support worldwide. For more information, visit: https://cdifffoundation.org/.
CutisPharma, Inc., based in Wilmington, Mass., is privately held, specialty pharmaceutical company that has been the industry leader for 20 years in providing innovative solutions to pharmacists. CutisPharma’s FIRST(r) 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, FIRVANQ(TM), 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: https://cutispharma.com/.