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FDA Approves First Oral Liquid Treatment for C. difficile-associated Diarrhea
CutisPharma announced that the FDA has approved Firvanq, an oral liquid for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, according to a press release.
The manufacturer said the approval will improve patient access by increasing availability and reducing the burden on pharmacists to make a compound.
“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 I. Muni, MD, MSPH, CEO of CutisPharma said in the press release.
Firvanq will be available in 25 mg/mL and 50 mg/mL strengths and will replace CutisPharma’s First-Vancomycin unit-of-use compounding kit.
CutisPharma expects the new product to launch in April.
“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,” Stuart Johnson, MD, of Loyola University Medical center said in the press release. “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.”
Disclosures: Muni is employed by CutisPharma. Healio Gastroenterology and Liver Disease was unable to determine Johnson’s relevant financial disclosures at the time of publication.