Tag Archives: Is there a liquid form of Vancomycin?

C Diff Foundation ‘Making a Difference’ Award Presented to CutisPharma Inc.

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

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/.

About CutisPharma:

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/.

 

Source:   https://enewschannels.com/c-diff-foundation-making-a-difference-award-presented-to-cutispharma-inc/

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