Ondansetron RapidFilm gains European approval


Suitable for children and adults with swallowing difficulties

BioAlliance Pharma has received DCP approval in 16 European countries for Setofilm, a filmstrip formulation containing 4mg and 8mg Ondansetron.

The product has been co-developed by Swiss healthcare company Applied Pharma Research (APR), German drug delivery specialist Labtec and US pharmaceutical firm MonoSol Rx. BioAlliance of France holds commercialisation rights for Europe.

According to BioAlliance, it is the first prescription drug product approved in a dosage form based on filmstrip technology on a worldwide basis.

BioAlliance will launch the Ondansetron filmstrip under the brand name Setofilm. The product is indicated for the prevention and treatment of chemotherapy- and radiotherapy-induced nausea and vomiting (CINV) in adults and in children aged 6 months and above, and the prevention and treatment of post-operative nausea and vomiting (PONV) in adults and children aged 4 years and above. The dosage form is said to be particularly suitable for patients having difficulties in swallowing, such as children and the elderly. Once placed in the mouth, it dissolves in a few seconds and is swallowed with the saliva without the need of water.

The total market for CINV and PONV in the seven major markets (top 5 EU countries, US and Japan) was approximately US$1.6bn in 2008. Ondansetron is the best-selling drug in this therapeutic class with total sales of around US$700m during the same period (2008, Datamonitor). Investigational uses of the drug include Parkinson’s disease, Schizophrenia, Irritable Bowel Syndrome and several other applications.

‘Given our shared expertise, this collaboration creates a unique opportunity to broaden the development reach for prescription film products,’ said Mark Schobel, president and chief executive of MonoSol.

‘We look forward to leveraging the capabilities and skills of our partners APR and Labtec as well as the unique attributes of our film strip technology to advance several drug targets for film delivery.’