FDA Approves Vancomycin Hydrochloride for Treatment of CDAD & Staphylococcus aureus Enterocolitis


The FDA has approved Firvanq for the treatment of C. diff-associated diarrhea and enterocolitis caused by Staphylococcus aureus.

A vancomycin hydrochloride oral solution for the treatment of Clostridium difficile-associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) has just been approved by the US Food and Drug Administration (FDA).

The solution, Firvanq, developed by CutisPharma, is projected to launch on April 2, 2018. When that happens, it will replace CutisPharma’s First-Vancomycin Unit-of-Use Compounding Kit, which has been available to provide pharmacists with a “convenient, accurate, and compliant way to compound vancomycin oral liquid therapy.”

The approved solution is available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes, and is designed for easy use. Furthermore, Firvanq 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 the press release.

Due to many new regulations in place, only a select number of pharmacies perform compounding in the outpatient setting; thus, CDAD patients have limited treatment options available to them. Availability of the FDA-approved therapy, however, will allow for any pharmacy to stock the treatment, and “hopefully encourage third-party payer reimbursement,” Stuart Johnson, MD, Loyola University Medical Center, said in the press release, which would improve accessibility and convenience for these patients.

“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,” Dr. Johnson wrote when discussing economic barriers in treatment options.

An earlier version of this article is available on MDMagazine.com.

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