Category Archives: Pharmaceuticals

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

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.

Super-bugs Capture Attention As A Worldwide Health Threat

About 2 million Americans catch drug-resistant infections each year, and 23,000 die, according to the CDC.

As superbugs capture attention as a worldwide health threat, Washington University will be part of a national campaign against drug-resistant bacteria with a $2 million federal grant. The Centers for Disease Control and Prevention awarded $14 million to 25 medical schools and other organizations for research into how microorganisms in the body, known as the microbiome, can track and prevent infections by outsider, drug-resistant germs.

“Understanding the role the microbiome plays in antibiotic-resistant infections is necessary to protect the public’s health,” Dr. Tom Frieden, CDC director, said in a statement. “We think it is key to innovative approaches to combat antibiotic resistance, protect patients, and improve antibiotic use.”

The microbiome includes “good” bacteria and other beneficial organisms that live in the skin and in the digestive and respiratory tracts. Antibiotics that are supposed to fight “bad” bacteria can disrupt the natural habitat by unbalancing the good and bad. Then drug-resistant bacteria can take over and create an environment for out-of-control bugs, including methicillin-resistant staphylococcus aureus (MRSA), carbapenem-resistant enterobacteriaceae (CRE) and clostridium difficile (C. diff.).

Overexposure to antibiotics has been blamed for the rise in superbugs, with the CDC estimating that one in three antibiotic prescriptions is unnecessary.

The research project will look at how early exposure to antibiotics affects the development of the microbiome and whether there are better ways to protect the microbiome.

Four teams of researchers at Washington University were named to the local project:

  • Dr. Jeffrey Henderson will lead a team working to identify how diet and metabolism interact with the gut microbiome in a study to combat C. diff. intestinal infections.
  • A team led by Gautam Dantas will study the long-term effects of antibiotic therapy in premature infants and how their digestive microbiomes are affected.
  • Dr. Jennie Kwon will study antibiotics and the microbiome as it relates to pneumonia.
  • Dr. Brian Gage will help look at hemorrhages linked to the use of blood thinners.

The United Nations General Assembly focused on superbugs — in a rare discussion of health issues. The meeting comes after a new superbug resistant to last-resort antibiotics infected a Pennsylvania woman over the summer, and a resistant strain of E. coli was recently found in a 2-year-old Connecticut girl.

The CDC recommends increased testing for the superbug gene among certain types of E. coli bacteria that show resistance to the powerful antibiotic colistin. The gene spreads readily among bacteria, and it could make these multi-drug-resistant strains almost impossible to treat.

A cluster of gonorrhea infections in Hawaii has shown resistance to all treatments. Doctors are increasingly worried that the common sexually transmitted disease is gaining strength as one of the most urgent superbug threats. If untreated, the disease can lead to infertility.

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

http://www.stltoday.com/lifestyles/health-med-fit/health/antibiotic-resistance-focus-of-washington-university-and-national-research-project/article_b192afec-7dbe-59b8-8e06-5e64b7d8795c.html

Lab Testing Is Critical For Persistent Diarrhea To Accurately Diagnose and Treat

An accurate diagnosis via laboratory testing is critical for effectively treating persistent diarrhea lasting more than 2 weeks, as the often poorly recognized syndrome can be caused by different pathogens than acute diarrhea, according to a clinical review recently published in JAMA.

“I’d like to educate doctors about the importance of taking the history and assessing duration of illness,” Herbert L. DuPont, MD, Director of the Center for Infectious Diseases at The University of Texas Health Science Center at Houston School of Public Health, said in a press release. “For acute diarrhea, the lab has a minimal role, restricted to patients passing bloody stools. If a patient has had diarrhea for 2 weeks or more, the doctor should focus on the cause of the disease through laboratory testing, with an emphasis on parasites.”

DuPont performed a review of relevant literature published up to February 2016 to provide an overview of the epidemiology, etiology, diagnosis and management of persistent diarrhea in immunocompetent patients.

Common causes of persistent diarrhea

Although acute diarrhea is usually caused by viruses or toxins, persistent diarrhea is usually caused by bacteria or parasites, DuPont wrote.

Protozoa are the most common parasitic cause of persistent diarrhea, including Giardia, Cryptosporidium and Cyclospora, whereas Entamoeba histolytica, Cystoisospora belli, Dientamoeba fragilis, Strongyloides stercoralis and Microsporidia species are less common.

Bacterial species that may cause persistent diarrhea include enteroaggregative Escherichia coli, Shigella, Campylobacter, Salmonella, Vibrio parahaemolyticus, Arcobacter butzleri and Aeromonas species.

Clostridium difficile can cause recurrent diarrhea in patients receiving antibiotics in health care settings, and viral agents, such as norovirus, and helminths can also cause persistent diarrhea.

“Parasites are more common in the developing world. Consequently, persistent diarrhea is more common in these areas and in local populations or people traveling to these locations,” DuPont wrote. “Persistent diarrhea occurs in approximately 3% of international travelers to developing regions.” Parasitic infection is less common in industrialized regions, where foodborne and waterborne pathogens and C. difficile are more common causes, he added.

Persistent diarrhea can also have noninfectious causes, including lactase deficiency, ingested osmotic substances, postinfectious irritable bowel syndrome, functional bowel diseases, inflammatory bowel disease, celiac disease, ischemic or microscopic colitis, carbohydrate malabsorption, cancer and other idiopathic illnesses.

Complete evaluation, new diagnostic methods

Duration of illness should be determined by health care providers when developing an evaluation plan, and the clinical assessment of patients with persistent diarrhea lasting more than 14 days should include a complete history, physical examination and diagnostic testing for infectious or noninfectious etiologies.

“The longer the duration of illness, the more likely it is that parasitic pathogens or noninfectious causes will eventually be identified,” DuPont wrote.

Previously, bacterial pathogens were identified using stool culture-based methods, and parasites are often identified using commercial enzyme immunoassay tests or microscopy. However, the recent advent of multiplex polymerase chain reaction (PCR) platforms enable simultaneous testing for a number of bacterial, viral and parasitic enteropathogens by identifying their DNA sequences.

The xTAG Gastrointestinal Pathogen Panel (Luminex Corp) tests for 14 viruses, bacteria, and parasites and the FilmArray GI panel (Biofire Diagnostics) tests for 22 viruses, bacteria, and parasites.

“These new tests are easy to use, are capable of detecting a broad range of pathogens and represent a significant improvement over culture-based diagnostic approaches,” DuPont said in the press release. “The technology needs to be more widely available. Diagnosis is critical when treating persistent diarrhea.” However, false positive results are problematic, he wrote.

Treatment depends on diagnosis

After treating any dehydration with oral rehydration therapy, a laboratory test should be performed to determine the cause of persistent diarrhea to determine the appropriate treatment. However, a single 1,000 mg dose of empirical azithromycin is appropriate concurrent to the lab test for adults who have traveled to the developing world, as bacterial causes that lab tests cannot usually identify are common.

Although antimicrobial agents are recommended for a number of pathogens, the antibiotic choice should be optimized based on the pathogen’s susceptibility to prevent antimicrobial resistance.

TO READ THE ARTICLE IN ITS ENTIRETY CLICK ON THE LINK BELOW:

A Study Provides Data That Between 2010 and 2011 Throughout U.S. At Least 30 Percent of Antibiotics Unnecessarily Prescribed

Antibiotics Unnecessarily Prescribed!

At least 30 percent of antibiotics are unnecessarily prescribed, contributing to the rise of debilitating and sometimes deadly bacteria-resistant superbugs, according to a study released Tuesday – May 3, 2016.

To reach this conclusion, researchers tracked antibiotic use in doctors’ offices and emergency departments between 2010 and 2011 throughout the United States. The study results were published in Journal of the American Medical Association by the Centers for Disease Control and Prevention along with Pew Charitable Trusts.

The findings showed that doctors needlessly wrote prescriptions for viruses, such as the common cold, viral sore throats and other ailments that can’t be cured with antibiotics. More than 47 million excess prescriptions put patients in harm’s way for allergic reactions and superbugs, such as Clostridium difficile, or C. diff.

“The rampant misuse of antibiotics is probably the leading infectious disease public health threat the world faces,” Dr. Amesh Adalja, a UPMC infectious disease specialist, said after learning of the study results. “The spread of antimicrobial-resistant bacteria and the infections they cause are a crisis and, if allowed to continue, will drag civilization back decades.”

Superbugs kill 23,000 Americans a year and sicken 2 million, according to the CDC.

Last year, the White House set its sights on superbugs, releasing a plan to combat the proliferation of antibiotic-resistant bacteria. The plan’s goal is to reduce outpatient antibiotic use by 50 percent and inpatient use by 20 percent by 2020.

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

http://triblive.com/news/adminpage/10409989-74/antibiotics-antibiotic-doctors

FDA Has Granted Appili Therapeutics Orphan Drug Designation For ATI-1501 (metronidazole) For Potential Treatment Of C. diff. Infection (CDI) In Children

IN THE NEWS

“Pediatric” CDI future medication treatment option.s

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

ATI-1501 is a taste-masked reformulation of metronidazole. For most children, metronidazole tablet is highly unpalatable due to its bitter taste. This reformulation has the potential to improve compliance rates in children in need for a safe and effective treatment for CDI.

The company intends to initiate clinical trials for ATI-1501 by 2017.

For more information visit Appilitherapeutics.com.

 

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

http://www.empr.com/drugs-in-the-pipeline/palatable-cdi-tx-for-children-designated-orphan-drug-status/article/489096/

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.