FI℞ST® – Vancomycin compounding kits make pharmacy compounding easier

Woburn, Mass., April 30, 2014– CutisPharma, Inc. announced the introduction of FI℞ST® – Vancomycin oral solution compounding kits. With FI℞ST®– Vancomycin, the oral solution is compounded within a minute by adding the pre-measured white grape flavored solution to the pre-weighed vancomycin hydrochloride powder bottle and shaking it. The pleasant white grape flavor helps mask the typical bitterness of vancomycin hydrochloride. These kits are provided in two concentrations 25 mg/mL, 5 oz., and 10 oz. sizes, and 50 mg/mL, 5 oz., 7 oz., and 10 oz. sizes for MultiFlex™ (multiple and flexible) dosing.

For many years metronidazole and oral vancomycin have been used for the treatment of Clostridium difficile (C. diff.) First-line therapy, for mild to moderate cases, is restricted to metronidazole. Second-line therapy for severe infections and/or treatment failure is oral vancomycin. In 2011, Dificid® (fidaxomicin) was introduced to the market for the treatment of C. diff.) -associated-diarrhea only in patients 18 years of age and older. Given that there are only oral solid dosage forms which are commercially available for all 3 of these antibiotics, metronidazole and vancomycin are commonly prepared as oral suspensions/solutions to accommodate the pediatric and geriatric populations which typically encounter difficulty swallowing these solid oral dosage forms and/or patients requiring feeding tubes. With these needs in mind, FI℞ST® – Vancomycin is now providing a grape-flavored, oral vancomycin solution for compounding in two concentrations and various package sizes.

In the United States, there are approximately 500,000 cases of C. diff. infections each year; and, about 70% of these cases are treated in the hospital. C. diff. continues to be on the rise, even in the pediatric population, according to recent studies.

Commonly, pharmacists will use lyophilized, sterile vancomycin hydrochloride powder for injection and sterile water for injection to compound an oral vancomycin solution. This oral solution tends to be very unpalatable for patients. The current method is not only cumbersome but also time-consuming; on average, it is taking up to 20 minutes of a pharmacist’s time.

“Our Company Mission Statement is to simplify the practice of traditional pharmacy compounding and to improve end user’s (Customers’) satisfaction for compounded drug products.” said Dr. Indu Muni, founder, chairman, and CEO of CutisPharma, Inc.

CutisPharma now has twenty four proprietary prescription compounding kits on the market: five progesterone suppository compounding kits, two testosterone kits, one hydrocortisone kit, five Magic Mouthwash kits, three omeprazole suspension kits, three lansoprazole suspension kits, and five vancomycin solution kits. Several more compounding kits are in the planning stages. The use of FI℞ST® Unit-of-Use Prescription Compounding Kits facilitates compliance with United States Pharmacopeia (USP) Chapter <795>.

The prescription compounding business is estimated to be worth as much as $9 billion annually, according to Pharmacy Commerce May/June 2013 issue. Prescriptions are prepared through “compounding,” a means by which a pharmacist prepares a customized medication according to a doctor’s prescription to meet an individual patient’s medical need.

About CutisPharma

CutisPharma, Inc. based in Woburn, MA, is a privately held, specialty pharmaceutical company focusing on the development and commercialization of value-added proprietary drug products and technologies in the prescription compounding sector of the pharmaceutical industry. Product line and development efforts are focused on providing optimized, more efficient alternatives for the preparation of the nearly 20 million currently compounded prescriptions, by offering FI℞ST® Unit-of-Use Prescription Compounding Kits. Use of these branded compounding kits will be beneficial to all triad participants, namely physicians, pharmacists, and patients. Four U.S. patents have been issued to the Company with additional patents pending, including “Composition and Method for Vancomycin Oral Liquid”.


James Nagle
V.P. Business Development
CutisPharma, Inc.
781-935-8141 x120

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