CutisPharma, Inc. today announced that it has received approval from the United States Patent and Trademark Office for its patent (US 7,815,929) regarding a method for the preparation, storage and dispensing of compounded suppositories.
"By its very nature, the process of compounding suppositories is cumbersome, time-consuming and in general, without adequate compensation," said Dr. Indu Muni, founder, chairman, and CEO of CutisPharma, Inc. "Our container (suppository mold) and the method for suppository-compounding is user-friendly and time saving for a pharmacy. Our suppository mold is also customer friendly because the take-home molds are especially designed to not only maintain the integrity of each suppository once compounded, but also provide convenient patient dispensing," he added.
The patented container is currently used in CutisPharma's FIRST® Progesterone Vaginal Suppository Unit-of-Use Prescription Compounding Kit product line which includes FIRST® - Progesterone VGS 25, 50, 100, 200 and 400 representing various strengths (mg.). The kits are made for a single patient and include pre-weighed progesterone, and suppository base, and a disposable container/mold for preparation, storage, and dispensing of the suppositories. A single NDC number assigned for the entire kit aids the third party reimbursement process, reduces audit- related adjustments, and the use of these FIRST® kits facilitates compliance with USP Chapter <795>.
CutisPharma estimates that over 1.5 million progesterone suppository prescriptions are written in the U.S. annually, representing a potential of nearly $100 million at the retail level. The Kit allows a pharmacy an easy entry into this market. The Company is experiencing a steady conversion from the conventional way to the FIRST® - way.
FIRST® products save dispensing time, are easy to use, and can be compounded by the pharmacist while the patient waits increasing customer satisfaction. Using FIRST® VGS kits, the pharmacist can compound a prescription for 30 vaginal suppositories 4 to 5 times faster than those prepared by the traditional method using a metal suppository mold or polystyrene shells. This is based on a study that was conducted by researchers at the Massachusetts College of Pharmacy and Health Science and published in the International Journal of Pharmaceutical Compounding in July/August 2009.
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