Ondansetron RapidFilm is an oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy and surgery.
SciClone Pharma claimed that Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
BioAlliance was granted approval under the EU decentraliaed procedure in 16 major EU countries. SciClone has acquired the commercialisation and distribution rights for ondansetron RapidFilm from APR for the People’s Republic of China, Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone’s efforts to secure regulatory approval for the product in these countries.
SciClone Pharma said that based on the European approvals, it is now planning to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong and Macau. SciClone expects to introduce the product through its existing sales organisation.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China’s growing pharmaceutical market.
Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals, said: “We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts.
“The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval.”