FDA Accepts CutisPharma's Vancomycin Hydrochloride for CDAD, Staphylococcus Aureus Colitis


The oral liquid therapy is expected to improve patient access and reduce pharmacist burdens by no longer compounding liquid formulations.

The US Food and Drug Administration announced the approval of CutisPharma’s vancomycin hydrochloride (Firvanq) an oral solution for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

Once launched April 2, 2018, Firvanq will replace CutisPharma’s First-Vancomycin Unit-of-Use Compounding Kit. The kit has been available to pharmacists in need of a convenient, accurate and compliant way to compound vancomycin oral liquid therapy.

Firvanq, available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes, is designed for easy use and has the potential to be a cost-effective alternative to existing vancomycin therapies.

“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,” Neal Muni, MD, MSPH, chief executive officer, CutisPharma said in a statement.

Patients with CDAD have limited treatment options since only a select amount of pharmacies perform compounding in the outpatient setting. With the upcoming availability of the oral liquid treatment, all pharmacies will be able to stock the therapy, significantly improving accessibility and convenience. Having an affordable and accessible treatment option is beneficial to patients, as oral vancomycin capsules are still “inexplicably expensive".

“Given the increasing role of vancomycin in the management of C. difficile infection, efforts should be made to lower the costs and improve access to this antibiotic,” Stuart Johnson, MD, professor of infectious disease, Loyola University Chicago Stritch School of Medicine, said when discussing economic barriers in treatment options.

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