On January 16, 2013 MonoSol Rx, the developer of PharmFilm drug delivery technology, reported that it has licensed Zuplenz (ondansetron) to Vestiq Pharmaceuticals, a specialty pharmaceutical company focused on innovative therapeutic remedies within the supportive care markets (Press release, MonoSol Rx, JAN 16, 2013, View Source [SID:1234508916]). Zuplenz is an oral soluble film (OSF) for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting. The licensing agreement comprised an undisclosed upfront payment from Vestiq, as well as double digit royalty payments from sales of Zuplenz. Vestiq relaunched Zuplenz in the United States in the fourth quarter of 2012. The approval of Zuplenz by the U.S. Food and Drug Administration (FDA) makes it the first oral soluble lingual film product approved by the FDA as a prescription medication, based on MonoSol Rx’s proprietary PharmFilm technology.
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A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are excited that Zuplenz is once again available to meet the needs of patients. We have found the right partner in Vestiq Pharmaceuticals and are excited about their ability to positively impact the supportive care market. We know that this oral film delivery of the drug ondansetron fulfills a significant unmet need, as we have fielded a continuous stream of inquiries from doctors and nurses regarding the availability of Zuplenz. Providers are now able to ensure their patients receive the best care possible by utilizing our innovative drug delivery technology to eliminate swallowing issues and discomfort associated with chemotherapy, radiotherapy, and surgery. Today’s announcement reinforces MonoSol Rx’s position as a leader in the film space, and our continued dedication to patients in need."
"We are pleased to be working with MonoSol Rx to relaunch Zuplenz into the U.S. market," said Martin Baum, Chairman and CEO of Vestiq Pharmaceuticals. "The oral film delivery technology is a major breakthrough for ease of use and compliance for supportive care patients, who consistently have difficulty swallowing. We intend to build on the initial acceptance of Zuplenz by the oncologists, general surgeon and oncology nurse communities, who are now able to provide their patients with an alternative product for nausea and vomiting."
Zuplenz is a unique formulation of ondansetron developed using MonoSol Rx’s proprietary PharmFilm technology, and co-developed with partner APR Applied Pharma Research s.a. of Switzerland. It is based on a novel and proprietary oral drug delivery technology platform and consists of a polymeric OSF containing ondansetron. Once placed in the mouth, it dissolves in a few seconds and is swallowed with saliva without the need for water.