Category Archives: C diff Treatments

Extended-pulsed fidaxomicin Found Superior to Standard-dose vancomycin To Treat C.difficile Infection In Older Adults

In a randomized, controlled, open label phase 3b/4 trial (ClinicalTrials.gov identifier: NCT02254967), hospitalized patients age 60 years and older with confirmed C difficile infection were recruited from 86 European hospitals. Patients were randomly assigned to receive extended-pulsed fidaxomicin (200-mg oral tablets, twice daily on days 1–5, then once daily on alternate days on days 7-25) or vancomycin (125-mg oral capsules, 4 times daily on days 1-10).

Of the 177 patients receiving fidaxomicin, 124 (70%) achieved the primary end point of sustained clinical cure 30 days posttreatment, compared with 106 (59%) of 179 who received vancomycin (odds ratio 1.62; 95% CI 1.04-2.54, P =.03).

Multivariate analysis, which included treatment arm and baseline stratification factors (infection severity, cancer presence, age, and number of previous C difficile infection occurrences) as covariates, also indicated fidaxomicin to be superior (P =.035). A subanalysis of microbiota diversity concluded that microbiota recovery was greater in the fidaxomicin group, and a Cox proportional hazards model suggested that the hazard of infection recurrence in the vancomycin group was 3.8 times greater.

This study demonstrates the superiority of extended-pulsed fidaxomicin treatment over standard treatment with vancomycin. The researchers note the absence of blinding and racial diversity in the study group as limitations and recommend that future investigations should study this treatment course in patients age 60 years and younger and should compare this treatment course with standard fidaxomicin treatment protocols.

Disclosure

The study was funded by Astellas Pharma Inc, who were involved in all stages of the study, including manuscript preparation.

Reference

Guery B, Menichetti F, Anttila V-J, et al.; for the EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. [published online December 19, 2017]. Lancet Infect Dis. doi: 10.1016/S1473-3099(17)30751-X

 

To read the article in its entirety please click on the following link:

https://www.infectiousdiseaseadvisor.com/clostridium-difficile/extended-pulsed-fidaxomicin-vs-vancomycin-sustained-clostridium-difficile-infection-cure/article/738757/

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.

 

CutisPharma Partners With C Diff Foundation To Support C.difficile Infection Awareness and Advocacy Efforts

 

CutisPharma and the C Diff Foundation announced the launch of a partnership beginning on November 1, 2017, the first day of Clostridium difficile awareness month.  As part of the partnership, CutisPharma awarded an unrestricted grant to the Foundation to further support its awareness efforts.

“We are pleased to partner with the C Diff Foundation and support its education and advocacy efforts benefiting patients impacted by Clostridium difficile Infection,” said Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma.  “It’s our hope that our work together can make positive strides in building awareness of this life-threatening condition that affects over a half-million patients in the United States annually.”

The nonprofit C Diff Foundation is dedicated to supporting global public health initiatives for Clostridium difficile Infection (CDI), also called C. difficile or C. diff – for infection prevention, treatments and environmental safety.

“We are very thankful for CutisPharma’s support of our foundation’s efforts,” said Nancy Caralla, Foundress and Executive Director of the C Diff Foundation, who is both a nurse and a three-time C. difficile survivor who also lost her father to a C. difficile infection.  “CutisPharma’s mission to improve the lives of patients with unmet medical needs is aligned with our foundation’s goals, and we look forward to partnering with Neal and his team to further our education and advocacy efforts on behalf of patients and survivors.”

CutisPharma has undertaken several initiatives to expand from its traditional base of making compounding kits for pharmacists, including the development and commercialization of FDA-approved drugs. The filing of the Company’s first FDA New Drug Application earlier this year, by its RM Therapeutics subsidiary, was a key milestone in the Company’s expansion goals.

About CutisPharma

CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company that has historically developed and distributed kits used by pharmacists to safely create compounded medications for nearly 20 years.  The Company’s products include oral solutions and suspensions, such as antimicrobials, mouthwashes, and PPIs; topicals, including hydrocortisone; and suppositories, including progesterone VGS.  CutisPharma’s FIRST Unit-of-Use 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.  For more information, visit www.cutispharma.com.

Researchers From Loyola Medicine Retrospectively Studied 100 Vancomycin Taper and Pulse Treatment Patients Treated For Recurrent C. difficile Infection

A tapered and pulsed regimen with vancomycin — with diligent follow-up — can achieve significant cure rates in recurrent Clostridium difficile (C. difficile) infected patients, according to a new study.

Researchers from Loyola Medicine retrospectively studied 100 vancomycin taper and pulse treatment patients treated for recurrent C. difficile infection between January 1, 2009 and December 31, 2014. Their clinic, the study authors wrote, has been a referral center for the infection for the past decade.

To read the article in its entirety please click on the following link:

http://www.mdmag.com/medical-news/pulsed-and-tapered-vancomycin-likely-route-to-recurrent-clostridium-difficile-cure

However, despite the guidelines for treatment of recurrent C. difficile infection being not too different than recurrent episodes – except for the use of vancomycin when the case is severe – there have not been many studies on this vancomycin taper and pulsed dosing. 

The researchers observed that after a referral, the confirmed recurrent C. difficile patients were treated with a vancomycin taper and pulse regimen: a taper of vancomycin to once-daily, followed by alternate day dosing; or once-daily followed by alternate day dosing; followed by every third day, for at least 2 weeks. After this regimen, all patients had 90-day follow-up documentation.

On average, the patients in the clinic were on their third C. difficile diarrhea episode. Half of the patients had also received a standard course of vancomycin, while another third had received some type of vancomycin taper regimen, the researchers said.

Despite the fact that many of these patients were a “treatment experienced” population, 75% of the patients who received a supervised vancomycin taper and pulsed regimen achieved a cure,  study author Stuart Johnson  MD, . He added that the results were further improved for patients who received the expended pulse phase: 81% achieved a cure.

“The findings were not unexpected to us, but I think that many clinicians will be surprised how well a deliberate, prolonged vancomycin taper and pulse regimen – with careful follow up – works,” Johnson said.

There were no significant differences among the patients in terms of gender, age, concomitant antibiotics, proton pump inhibitor use, histamine receptor-2 blocker use, or patients with a regimen greater than 10 weeks in length, the researchers continued.

The researchers added that their finding of improved cure rates with alternate-day dosing plus every third day dosing over strictly alternate-day dosing is consistent with the hypothesis that pulsed dosing can promote a cyclical decrease in spore burden, they wrote. This can also permit the resetting of normal microbiota in the gut.

Johnson concluded that the clinical implications of the study show most recurrent C. difficile patients do not need fecal microbiota transplant (FMT).

“FMT has received an enormous amount of press and this procedure is now widely available throughout the US,” Johnson said. “FMT is attractive because it addresses one of the primary mechanisms involved with recurrent C. difficile infection, a marked disruption of the resident bacteria that populate the intestine and provide an important host defense against C. difficile.

Although physicians screen donor feces for “known pathogens,” not all is known of the potential complications to come from FMT, Johnson said.

“In addition, it appears that efficacy with a carefully supervised vancomycin taper and pulse regimen compare to that achieved with FMT,” Johnson said.

The study, “Vancomycin Taper and Pulsed Regimen with careful Follow up for Patients with Recurrent Clostridium difficile Infection,” was published in the journal Clinical Infectious Diseases.