MonoSol Rx, the developer of PharmFilm® drug delivery technology, has licensed Zuplenz® (ondansetron) to Vestiq Pharmaceuticals. Zuplenz is an oral soluble film (OSF) for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting.
The licensing agreement includes up-front 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. According to the company, the approval of Zuplenz by the FDA makes it the first approved oral soluble lingual film product.
“The oral film delivery technology is a major breakthrough for ease of use and compliance for supportive care patients, who consistently have difficulty swallowing,” said Martin Baum, chairman and CEO of Vestiq. “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 PharmFilm technology, and co-developed with partner Applied Pharma Research of Switzerland. It consists of a polymeric OSF containing ondansetron, which once placed in the mouth dissolves in a few seconds and is swallowed with saliva without the need for water.
In November 2012, MonoSol Rx entered into a partnership with BiondVax to develop an oral film formulation of BiondVax’ universal flu vaccine, M-001. According to the company, the advantages for this needle-free delivery in vaccines include ease of use, increased compliance, and simplified distribution.