FDA Approves Novel C. Difficile Drug

The FDA recently approved (Firvanq) for the treatment of Clostridium Difficile associated diarrhea (CDAD) and Staphylococcus aureus colitis. The oral liquid solution is an alternative to compound liquid formulations for the treatment of CDAD, according to a press release from CutisPharma.

“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.”

C. Difficile, a potentially fatal infection, is a leading cause of diarrhea among patients who are hospitalized and was declared an urgent public health threat by the CDC in 2013.

The most common symptoms of C. Difficile are diarrhea, abdominal pain, nausea, and fever, and the infection is likely to recur in a quarter of patients who have developed the infection. It is commonly spread from patient to patient in hospitals, and through exposure to antibiotics.

According to CutisPharma, more than half a million cases are treated annually in the United States.

CutisPharma stated in the press release that its new drug will be more accessible and affordable for patients with CDAD.

Notably, this therapy will also be more convenient for pharmacists by eliminating the need for compounding, according to the release.

“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.

Vancomycin hydrochloride will take the place of CutisPharma’s FIRST Vancomycin Unit-of-Use Compounding Kit. Although many patients have benefited from FIRST, few outpatient pharmacies have been able to perform compounding; this limits a patient’s access to treatment, according to the 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,” Dr Johnson said.

CurtisPharma designed the drug to be both convenient and cost-effective compared with alternative vancomycin-based therapies. The medication also benefits patients who cannot swallow conventional treatments such as pills or capsules, according to CurtisPharma.

Vancomycin hydrochloride 150 ml or 300 ml in 25-mg or 50-mg strengths are scheduled to be released on April 2, 2018, according to the press release.